Assembly and packaging method for needle and suture assemblies

ABSTRACT

An automated machine for attaching a suture to a surgical needle having a suture receiving opening formed therein, and for packaging the same in a package tray comprises a first workstation including a device for sorting a plurality of needles and orienting each needle for automatic feeding to a second swaging workstation, a second workstation including a device for automatically cutting an indefinite length of suture material to a definite length and a device for automatically swaging the needle to close the suture receiving opening about a free end of the suture to secure the suture thereto and form a needle-suture assembly, a needle packaging station including a device for sequentially receiving at least one of the needle-suture assemblies in a package tray in synchronism with the second workstation, the needle packaging station having a device for automatically winding the depending suture portion of the needle-suture assembly into the package tray, a first indexing device for sequentially receiving individual oriented needles fed from the first workstation and transferring each of the needles from the first workstation to the second workstation to form the needle-suture assembly thereat, the first indexing device sequentially indexing the needle-suture assemblies from the second workstation to the needle packaging station.

This is a divisional of application Ser. No. 08/181,606, filed on Jan.13, 1994.

FIELD OF THE INVENTION

The present invention relates generally to machines for producing armedsurgical needles, i.e., surgical needles having a suture strand ofpredetermined length attached at one end thereof, and machines forpackaging the same, and more specifically to a high-speed needle-sutureassembly and packaging system that automatically assembles armedsurgical needles and packages them in a organized package of uniqueconstruction.

DESCRIPTION OF THE PRIOR ART

Presently, armed surgical needles used by surgeons and medical personnelare manufactured utilizing manual and semi-automated procedures such asthose described in U.S. Pat. Nos. 3,611,551, 3,980,177, and 4,922,904.For instance, as described in U.S. Pat. No. 3,611,551, manualintervention is required by an operator to accurately position a suturetip within a suture receiving opening of a surgical needle to accomplishswaging thereof. This process is costly in terms of man-hour labor andefficiency because of the manual manipulations involved.

Indefinite length of suture material may be supplied wound on a bobbin,or, a king or driven spool before being cut and positioned within theswaging end of a surgical needle. In U.S. Pat. No. 3,980,177 the suturematerial is fed from a spool and taken up on a rotating tension rackwhere uniform length strands are subsequently cut. Thus, the length ofthe suture is determined by the size of the rack and manual interventionis required to prepare the rack for the cutting of the suture materialwound thereabout. Moreover, manual intervention is required to changethe rack each time a suture strand of different length is desired.

In U.S. Pat. No. 4,922,904, the suture material is supplied wound on abobbin and is fed through various guide means prior to insertion withinthe suture receiving end of the surgical needle. In one embodiment showntherein, an elaborate television monitoring means is required foraligning the drawn suture within the suture receiving opening of thesurgical needle prior to swaging thereof. In the same embodiment, arotary encoder device is used to determine the length of suture materialunwound from the bobbin prior to cutting. In an alternative embodiment,after swaging of the indefinite length of suture material to the needle,the needle-suture assembly is additionally fed a predetermined distanceprior to cutting to obtain a suture strand of predetermined length.Thus, to obtain uniform lengths of suture material every time requirescareful manipulations and precise controls, and the processes used toaccomplish these tasks are slow and inefficient.

Additionally, at the present time, the introduction of needles withattached sutures into suture packages or molded plastic trays is beingimplemented in a substantially manual manner. In that instance, theneedles are manually placed into the tray so as to be clampingly engagedby means of suitable needle-gripping structure, and thereafter theattached sutures are wound or positioned within the confines of thetray. Subsequently, a suitable cover is superimposed upon and fastenedto the filled tray, and the resultant suture package conveyed to asuitable arrangement for possible sterilizing or further overwrapping.

The foregoing essentially manual and relatively basic process forwinding the sutures into the tray, and especially the locating thereofinto a peripheral channel of the tray during manipulation of the tray,is quite time-consuming, and in conjunction with the manual applicationof the cover into the tray in a basically individual or piece-by-piecemode, represents a serious hindrance to a high volume mass producedmanufacturing output, and adversely affects the economics in attemptingto provide such large quantities of suture packages containing multiplesurgical needles and attached sutures.

In view of the limitations of the devices described in theaforementioned patents, it would be desirable to provide a needle-sutureassembly and packaging system that is fully automated and which canautomatically prepare surgical needles having uniform lengths of suturematerial attached thereto.

Furthermore, it would be desirable to provide a needle-suture assemblyand packaging system facilitating the automated high-speed packaging ofsurgical needles having sutures attached thereto.

Furthermore, it would be highly desirable to provide an automatichigh-speed needle threading and swaging system and automatic high-speedpackaging system that is computer controlled and that can provideautomatic adjustments to the swage tooling dies when different sizesutures are swaged to correspondingly sized surgical needles.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide anautomatic needle-suture assembly and packaging machine for producing andpackaging armed surgical needles in a package of unique constructionand, packaging the same that is operable under the control of a controlsystem computer.

It is another object of the instant invention to provide acost-effective automatic needle-suture assembly and packaging machinethat virtually eliminates operator exposure to any repetitive manualoperations.

It is still another object of the instant invention to provide anautomatic needle-suture assembly and packaging machine that incorporatesa rotatable swage dial having a plurality of multi-axis grippers thatautomatically grip surgical needles for indexing to a plurality ofprocessing stations that include: a loading station for transferringindividual precisely oriented surgical needles from a conveyor to themulti-axis grippers; a swaging station that automatically draws anindefinite length strand of suture material, cuts the strand, insertsthe free end of the definite length strand within the suture receivingend of the needle, and swages the suture strand to the surgical needle;a pull-test station that automatically performs minimum and n-countdestructive pull-testing of the needle-suture combination; and finally,a needle-suture load to package station where armed, pull-tested needlesare transferred to the automatic packaging station for packagingthereof.

Yet another object of the present invention is to provide an automaticneedle-suture assembly and packaging machine that incorporates arotatable suture winding and packaging dial having a plurality toolnests, each for supporting a package tray for indexing to a plurality ofworkstations that include: a package load station for loading an emptypackage tray onto a supporting structure of the tool nest; a packagedetect station for detecting the presence of an empty package tray; aneedle-suture load to package station where armed needles aretransferred to the package from the rotary swage dial; a needle checkstation where the presence or absence of the armed needles is checked; awinding station where the sutures that depend from each surgical needleare gathered to a bundle and wound around a peripheral channel locatedabout the periphery of the package tray; a cover loading station where acover is applied to the package; and finally, a package removal stationwhere the completed package is removed from the machine, or rejected ifthe package is flawed.

Yet still another object of the present invention to provide ahigh-speed automatic needle-suture assembly and packaging machine thatis operable under the control of a control system computer and canprovide continuous on-line tool adjustments without unnecessaryinterruptions and without manual intervention.

These and other objects of the present invention are attained with anautomated machine for attaching a suture to a surgical needle having asuture receiving opening formed therein, and for packaging the same in apackage tray, the automated machine comprising: a first workstationincluding means for sorting a plurality of needles and orienting eachneedle for automatic feeding to a subsequent workstation; a secondworkstation including means for automatically cutting an indefinitelength of suture material to a definite length suture strand and meansfor automatically swaging the needle to close the suture receivingopening about a free end of the suture to secure the suture thereto andform a needle and suture assembly; a needle packaging station includingmeans for sequentially receiving at least one of the needle-sutureassemblies in a package tray in synchronism with the second workstation,the needle packaging station having a means for automatically windingthe suture into the package tray; a first indexing means forsequentially receiving individual oriented needles fed from the firstworkstation and transferring each of said needles from the firstworkstation to the second workstation to form the needle-suture assemblythereat, the first indexing means sequentially indexing theneedle-suture assemblies from the second workstation to the needlepackaging station, whereby unsorted needles and an indefinite length ofsuture material are automatically formed into a plurality of orientedneedle and suture assemblies and positioned within the package tofacilitate their orderly removal therefrom.

Further benefits and advantages of the invention will become apparentfrom a consideration of the following detailed description given withreference to the accompanying drawings, which specify and show preferredembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a conceptual top view of the needle threading and swagingmachine and automatic packaging machine that are operable under thecontrol system of the instant invention;

FIG. 2 is a detailed illustration of a typical surgical needle 9 havingan arcuate portion 8 and suture receiving end 7;

FIGS. 3(a)-3(e) are the general flow diagrams illustrating the processfor needle-suture assembly and packaging of the present invention;

FIG. 4 is a top plan view of the needle sorting station 100 of theautomated needle threading and swaging system;

FIG. 5 illustrates the precision conveyor handing off surgical needle 9to the retaining pin assembly of a multi-axis gripper 155;

FIG. 6 is a top view of the rotary swage dial assembly 150 comprising aswage dial plate 110 having four multi-axis gripper stations 145a,b,c,dmounted thereon;

FIG. 7(a) is cross-sectional view of the four station swage dialassembly 150 showing multi-axis gripper 155 in a retracted position;

FIG. 7(b) is cross-sectional view of the four station swage dialassembly 150 showing multi-axis gripper 155 in an extended position;

FIG. 8(a) is detailed top view of the cam dial assembly 120 having camdial plate 125 with cam follower 165a in a retracted position within camtrack 160a;

FIG. 8(b) is cut away top view of the cam dial plate 125 showing camfollower 165a in an extended position within cam track 160a;

FIG. 9 is a cross-sectional view of the cam dial plate 125 mountedcoaxial with the swage dial plate 110 for cooperative rotationalmovement thereof, and showing cam followers 165a and 165c positionedwithin their respective cam tracks 160a and 160c;

FIG. 10(a) is front view of the multi-axis gripper 155 showing pin 142in a retracted position and a surgical needle 9 in a relaxed state;

FIG. 10(b) is front view of the multi-axis gripper 155 showing asurgical needle 9 in an engaged position therein;

FIG. 11 is an enlarged view of a gripper assembly having gripper arms265a,265b shown in their closed (suture gripping) and open positions;

FIG. 12(a) is a detailed view of the servo assembly (suture drawing)tower 220 of the instant invention, and additionally showing amulti-axis gripper 155 indexed thereat;

FIG. 12(b) is a detailed side view of the cutting assembly of FIG. 12showing the pulley assembly for moving tip and cut carrier assembly 180of the instant invention;

FIG. 13 is a detailed view of the tensioner assembly 59 for increasingor decreasing suture strand tension as desired.

FIG. 14(a) is a detailed view of the gripper 232 shown inserting thesuture tip 258 within the confines of the suture receiving end of thesurgical needle;

FIGS. 14(b)-14(f) illustrate the multiaxis needle gripper 155 andswaging and suture alignment dies shown in various stages of the sutureinsertion and needle swaging sequence.

FIG. 15(a) is a top view of the swage assembly 390 of the instantinvention with the multi-axis gripper 155 indexed thereat;

FIG. 15(b) is a detailed view of the swage stop mechanism for swageassembly 390.

FIG. 16 is a detailed top view of the cutter assembly 280 in the instantinvention;

FIG. 17(a) is a detailed top view of the cutter assembly 280 shown in afully retracted position;

FIG. 17(b) is a detailed top view of the cutter assembly 280 shown in afully extended (cutting) position;

FIG. 18 is a detailed top view of the tipping assembly 290 for heating aportion of the suture material;

FIG. 19(a) is a detailed top view of the swage dies 361,369 of theswaging assembly showing the recesses 321,322 formed in the swage dieopening 392 located therebetween;

FIG. 19(b) is an enlarged view of the swage die opening shown encircledin FIG. 19(a);

FIG. 20 is an assembly drawing of the automatic pull-test station 300 ofthe instant invention;

FIG. 21(a) is a front view of the automatic pull-test station 300 of theinstant invention with the needle fence assembly 340 partially removed.

FIG. 21(b) is a detailed front view of the slide assembly means whileperforming a minimum pull-test.

FIG. 21(c) is a detailed front view of the slide assembly means whileperforming a destructive pull-test.

FIG. 22 is a top view of the load cell assembly 330 of the automaticpull-test assembly;

FIG. 23 is an enlarged view of an armed needle 9 supported by the suturereceiving blade 336b of the load cell 335 with the suture threadedbetween the suture receiving opening 334;

FIG. 24 is a detailed view of the needle stripper assembly 380 forremoving the needle 9 after a destructive pull-test or after minimumpull-test failure;

FIG. 25 illustrates a top plan view of the suture wind and packagingturret of the automatic packaging machine for needle-suture assemblies;

FIG. 26 illustrates, on an enlarged scale, a detailed side view of therotary disk showing one of the tool nests for mounting a needle andsuture-receiving tray;

FIG. 27 illustrates a front view of the tool nest of FIG. 26;

FIG. 28(a) illustrates a fragmentary top view of the rotary turret,showing an enlarged portion thereof incorporating one of thetray-mounting tool nests;

FIG. 28(b) illustrates an enlarged fragmentary detail of the encircledportion in FIG. 28(a);

FIG. 29 illustrates, generally diagrammatically a package detectorassembly operatively utilized in conjunction with the rotary disk asshown in FIG. 25;

FIG. 30 illustrates an elevational view of the detector assembly asviewed in the direction of line 30--30 in FIG. 29;

FIG. 31 is a perspective view of the discharge station 600 where rotarysuture winding and packaging turret 514 indexes empty package 420 forreceiving an armed needle from the multi-axis gripper 155;

FIG. 32(a) illustrates, on an enlarged scale, the suture tray of FIG. 46with the device for elevating the tray to enable a plurality of needlesto be parked therein;

FIG. 32(b) illustrates a side view of the suture tray;

FIG. 32(c) illustrates an enlarged fragmentary view of the encircledportion of FIG. 32b;

FIGS. 33(a) through 33(c) illustrate tilting mechanisms which areoperatively associated with the tray elevating device of FIG. 32.

FIG. 34 illustrates a side view of the needle detector arrangement;

FIGS. 35(a) through 35(c) schematically illustrate, respectively,various stages in the operation of the suture winding arrangement;

FIG. 36 is an enlarged fragmentary view of the encircled portion of FIG.35c;

FIG. 37 illustrates a side view of a suture retaining unit in operativecooperation with the winding arrangement of FIGS. 35(a) through 35(c);

FIG. 38 illustrates a top view of the suture retaining unit of FIG. 37;

FIGS. 39(a) through 39(c) illustrate, respectively, operative drivestructure for the suture winding arrangement, shown on an enlargedscale, taken along line 39--39 in FIG. 37;

FIG. 40 illustrates a front elevational view of the cover applyingdevice in two operative conditions thereof;

FIG. 41 illustrates a side elevational view of the cover-applying deviceof FIG. 40;

FIG. 42 illustrates a top plan view showing the cover-applying deviceand the cover-pressing die of FIG. 40;

FIG. 43 illustrates an elevational side view of a suture packageunloading arrangement in two operative conditions thereof;

FIG. 44 illustrates a view in the direction of the arrow 44--44 in FIG.43;

FIG. 45 illustrates, on an enlarged scale a fragmentary view of theencircled portion in FIG. 43;

FIG. 46 illustrates a front view of a tray having needles and suturesarranged therein;

FIG. 47 illustrates a perspective view of a completed suture package;and

FIG. 48 illustrates, on an enlarged scale, a sectional view of one ofthe latching elements between the tray and an associated tray cover.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Generally, as shown in the conceptual plan view of the needle threadingand swaging system and needle-suture packaging system of FIG. 1,parallel operations take place simultaneously at four (4) differentworkstations positioned about a rotary swage dial 150 to ensure a highrate of production of surgical needles having sutures attached thereto.Additionally, parallel operations take place simultaneously at eight (8)different workstations positioned about the larger suture winding andpackaging turret 500 where the armed surgical needles are automaticallyparked into a reduced size organizer package of unique construction.FIG. 2 illustrates a typical surgical needle 9 having a suture receivingopening or end 7 for swaging a suture strand thereto, and an arcuateblade portion 8.

The automatic needle threading and swaging portion of the inventionshown in FIG. 1 includes four workstations located about the peripheryof the rotary swage dial 150 that are successively utilized to formneedle-suture assemblies. These workstations include: a needle sortingstation 100 that sorts, singulates, and conveys precisely orientedsurgical needles to a plurality of retractable (multi-axis) grippersmounted on the rotary swage dial 150. The rotary swage dial 150successively rotates counter-clockwise as shown by arrow "A" in FIG. 1,to index each needle to the automatic swaging station 200 where thesuture material inserted into the needle, cut, and automatically swagedthereto. Next, the rotary swage dial 150 rotates further to index thearmed needle to the automatic pull-test station 300 where each armedneedle is pull-tested to ensure that minimum and/or destructivepull-test requirements are met. Then, the rotary swage dial 150 indexesthe pull-tested armed needle to a discharge station 600 where the armedsurgical needles are handed off to a package tray of unique constructionat the rotary suture winding and packaging turret 500 for automaticpackaging thereof. Hereinafter, the discharge station 600 will bereferred to as the needle-suture load to package station.

Generally, the automatic packaging portion of the invention shown inFIG. 1, includes eight (8) workstations located about the periphery ofthe rotary suture wind and packaging dial 510 that are successivelyutilized to form the completed package of surgical needles. Thesestations include: a package load station 400 for successively feeding anempty package onto a support plate of a tool nest mounted on thepackaging dial; an optional package detect station 450 for checking thepresence of the loaded empty package; the needle-suture load to packagestation 600; an optional needle check station 475 for detecting missingneedles; a suture winding station 550 where the trailing sutures of thearmed needles are gathered and wound into the package; an optionalmanual inspection station 625; a paper insert station 650 where a papercover is applied to the package; and, a package removal station 700where the completed package is removed from the machine for furtherprocessing, or, if the package has been found defective duringinspection, is scrapped.

All of the processes performed by the needle-suture assembly andpackaging system of the instant invention are under control of a controlsystem computer 99 as shown in FIG. 1. Alternatively, the control systemmay be implemented in a plurality of programmable logic controllers orother such suitable control devices (not shown).

To begin, the control system 99 initiates power up of the variousdevices utilized in the automatic needle-suture assembly and packagingsystem. At this point, an operator may be prompted to set up the diesfor the swaging assembly that correspond to the size of the batch ofneedles to be processed. Additionally, any other necessary adjustmentsand setups may be performed for each assembly, for e.g., to initializethe Adept® robot assembly at the needle sorting station 100, or, theneedle supporting blade of the load cell in the automatic pull-teststation 300. Also as part of the power up display, an operator may beprompted to choose between operating the system in the normal, fullyautomatic mode, or, in a single step mode for diagnostic andtrouble-shooting purposes.

FIGS. 3(a)-3(d) are block diagrams generally illustrating the automaticneedle-suture assembly and packaging system 10 of the instant invention.For instance, at the needle sorting apparatus 100, needles are firstloaded into a vibratory bowl at step 11, automatically sorted andlinearly fed at step 12 to a translucent indexing conveyor at step 13,evaluated with respect to orientation and position by a vision trackingsystem at step 14, picked up by a robot apparatus at step 15,transferred to a precision conveyor by the robot apparatus at step 16,and finally conveyed to a load station where the needles are transferredto a multi-axis gripper located on a rotary swage dial 150 forsubsequent transfer to the swaging station 200 indicated at step 17. Adetailed explanation of the apparatus used to carry out each step willbe explained in further detail hereinbelow.

Simultaneous with the needle sorting process described above withrespect to steps 11 through 17, an automatic suture cutting and swagingprocess is taking place at the swaging station 200 shown in FIGS. 3(a)and 3(b) with respect to steps 19 through 30. Indefinite length suturematerial is supplied in various spools and configurations that may carryup to 5000 yards of material. This is indicated at step 19 in FIG. 3(a).Next, at step 20, the suture material is loaded into a payoff assemblywhich is part of a drawing tower apparatus to be described in detailbelow. This payoff assembly includes grippers that alternately draw thesuture material from the spool to enable cutting thereof. When largerspools of material are used, the material may be optionally loaded in adriven spool feed assembly with a dancer as indicated at optional step21 to ensure that the material does not break or snap when in tension.

While the material is being drawn, it may require extra treatment orprocessing. For instance, as described in detail below, it may bedesirable to heat the suture material under tension at the suture tip inorder to stiffen the material to facilitate the positioning thereofwithin the suture receiving opening of a surgical needle. Thus, atoptional step 22, heat may be applied to a portion of suture material.At step 23 of the block diagram of FIG. 3(a), the suture material isgripped by the servo grippers. At step 24, the suture strand is drawn upthe tower and positioned for insertion within the suture receivingopening of the needle for swaging.

After a surgical needle is indexed to the swaging station 200 asdescribed above, the multi-axis gripper positions the needle in aprecisely oriented position at the swage die opening formed at the endsof two swaging dies of a swage assembly as indicated as step 26 in FIG.3(b). Simultaneously, the suture strand is drawn from a king spool alonga single axis of a drawing tower to register a tip thereof for insertionwithin the suture receiving end of the needle. Next, at step 27, thegripper assembly at the drawing tower inserts the tip of the suturestrand within a lower funnel guide for accurate positioning within thesuture receiving opening of the needle that is aligned with the suturedrawing axis. Then, at step 28, the multi-axis gripper releases its gripon the needle placed within the swage die opening. At step 29, the swagecylinder is activated to automatically swage the suture to the needleand to cut the indefinite length of suture strand at a predeterminedlength. While retaining the armed needle, the multi-axis gripper is thenretracted at its station on the rotary swage dial as shown as step 30and indexed to a pull-test station 300 at step 31 so that minimumpull-testing at step 32 or destructive pull-testing at step 33 may beperformed.

Depending upon the results of the minimum pull-test, the armed needlewill either be indexed by the rotary swage dial to the discharge station400 where the armed needle will be discharged to the suture winding andpackaging turret 500 if the pull-test requirements are met (as shown asstep 34a in FIG. 3(b)), or, will be discharged at the pull-test stationif the needle fails the minimum pull-test (as shown as step 34b in FIG.3(b)). The destructive pull-test always renders the armed needleincapable of further processing so the needle is automaticallydischarged at the pull-test station 400 as indicated at step 35 in FIG.3(b).

As indicated in FIG. 3(c), while the needle-suture assembly processesare being performed at the rotary swage dial, the automatic packagingprocesses are taking place About the suture wind and packaging turret500. As indicated as step 40 in FIG. 3(c), at the package load station400, an empty package tray is positioned on a tool nest located on therotary suture winding turret 500. At step 43, the empty package tray isindexed to an optional package detect station 450 for checking thepresence of the loaded empty package. Next, at step 45, the emptypackage tray is indexed to the needle-suture load to package station600. As will be explained in detail below, the empty package traysupport is engageable with an elevator assembly that successivelyregisters the package tray for sequential receipt of needles from therotary swage dial, as indicated at step 51. Then, as shown as step 55 inFIG. 3(c), armed needles that have passed the minimum pull-test areconveyed to a needle-suture load to package station 600 where up toeight individual armed needles are loaded into the package. As shown asstep 58 in FIG. 3(c), the package tray containing the armed needles areindexed to the optional needle check station 475 for detecting missingneedles. The next few steps take place at the suture winding station 550where the suture strands depending from the needles are first gatheredinto a bundle by a vacuum assembly as shown as step 61 in FIG. 3(d).Then, the package tray containing the armed needles is oriented at step64 to facilitate cooperative engagement with the winding stylus at step67 that is extended to position the gathered suture bundle within theperipheral channel of the package tray. Next, at step 70, the packagetray is rotated so the gathered suture bundle is wound around theperipheral channel. Finally, at step 73, the package tray containingarmed needles is indexed to an open station 625 which may be an optionalmanual inspection station. At the same time the package is indexed tothe open station, a package cover (lid) is loaded onto a grippingdevice, as shown at step 77, for attachment to the package tray at thepaper insert station 650. At step 80, the package tray is indexed to thepaper insert station 650 where the gripping device places the packagecover onto the package tray to form a completed package. Finally, asindicated at step 83 in FIG. 3(e), the completed package is indexed tothe package removal station 700 where the package is either dischargedfor further processing, as shown in step 87, or, if the package isdetermined to be flawed, is discharged to a reject bin as shown at step89.

Needle Sorting Station

The needle sorting station 100 sorts, singulates, and successivelyconveys individual and precisely oriented surgical needles to each offour multi-axis grippers indexed thereat by the rotary swage dialassembly 150, in the following manner:

At the needle sorting station 100 illustrated in FIG. 4, a batch ofunoriented needles of uniform size are first loaded into vibratory bowls101a,b, automatically sorted and linearly fed by singulating devices102a,b to each of two translucent indexing conveyors 105a,b, evaluatedwith respect to orientation and position by a vision tracking system(not shown), picked up by either of two robotic apparatuses 106a,b,transferred to individual engagement devices (boats) 108 located on aprecision conveyor 107 by each robot apparatus, and finally conveyed tothe rotary swage dial assembly where the needles are transferred to amultiaxis gripper for subsequent transfer to the swaging station 200 aswill be described in further detail below. A detailed explanation of theneedle sorting apparatus 100 is explained in further detail in copendingU.S. patent application 08/181,600 (attorney docket 8920), and adetailed explanation of the robotic control system utilized therein isdescribed in copending U.S. patent application 08/181,624 (attorneydocket 8921) both of which are assigned to the same assignee as thepresent invention, and incorporated by reference herein.

Rotary Swage Dial/Multi-axis Gripper

As indicated at step 17 in FIG. 3(a), the next step of the needlethreading and swaging process 10 involves the loading of the individualprecisely oriented surgical needle 9 from the precision conveyor boat108 onto the multi-axis gripper 155. At this point, the precisionconveyor boat 108 is in a vertical position on conveyor 107 and carryingneedle 9 in a precise orientation as shown in FIG. 5. As shown in FIG.5, the needle 9 is delivered from the engagement jaws 111,112 of theconveyor boat 108 to the multi-axis gripper 155 that has been indexed tothe needle sorting station 100 in opposed relation with the precisionconveyor boat 108.

In the frontal view of the multi-axis gripper 155 as shown in FIG.10(a), there is shown gripper pin assembly 152 comprising pins 142, 146,and 148 that extend perpendicularly therefrom to engage needle 9.Generally, to accomplish the transfer of the needle to a multi-axisgripper, the multi-axis gripper is extended from its retracted positionupon the swage dial assembly 150 in the manner described below, so thatpins 146 and 148 of the gripper pin assembly penetrate a plane formed bythe curvature of needle 9 positioned upon the precision conveyor boat108 as shown in FIG. 5. Then, the control system 99 initiates thecommand for a load solenoid or similar device to open engagement jaws111,112 of the precision conveyor boat 108 to release the needle 9 sothat it is deposited between the pins 146 and 148 of the multi-axisgripper 155. A front view of the multi-axis gripper 155 with needle 9positioned thereon after transfer from the precision conveyor boat 108is illustrated in FIG. 10(a). After the transfer, as controlled by thecontrol system computer, pin 142 is actuated from a non-engagingposition to an engaging position to thereby engage the needle 9 in anoriented position as shown in FIG. 10(b). The multi-axis gripper 155 isthen retracted from its extended position and the swage dial assembly150 is rotated to the swaging station 200 for automatic swaging of thesuture to the needle 9.

FIG. 10(b) illustrates pins 142 and 144 located along the outer arcuateportion of the needle, while pin 146 supports the pin at the innerarcuate portion 8 of the needle 9. The barrel portion 7 of the needle 9fits against a protruding stop 148 located on the gripper pin assembly152 of the gripper 155 as shown in FIG. 10(b). The location of the stop148 may be adjusted to accommodate the engagement of different sizesurgical needles. In the preferred embodiment, the gripper pin assembly152 is replaceable with other gripper pin assemblies having the stop 148positioned to accommodate different sized surgical needles. Note that inFIGS. 10(a) and 10(b), the suture receiving end portion 7 of needle 9extends below the gripper pin assembly 152 of the multi-axis gripper155. This enables placement of the suture receiving end 7 of the needlewithin the swage dies of the swaging assembly as will be explainedbelow.

The three pin needle engagement configuration shown in FIGS. 10(a) and10(b) ensures that needle 9 will not be displaced when the swage dial150 is rotating, or, when the multi-axis gripper 155 is being retractedor extended. In the preferred embodiment, pin 142 is spring loaded andis retractable within guide 147 to release its grip of needle 9 when aneedle is being transferred thereto or, when automatic swaging andpull-testing occurs. Retraction of pin 142 is activated by depressingplunger 149 by a suitable push rod or cam 143 as shown in the Figures.Pin 142 is biased back into the needle engaging position as shown inFIG. 10(b) by retracting the push rod or cam 143.

As illustrated in FIG. 1, the rotatable swage dial assembly 150 includesfour multi-axis gripper stations where simultaneous needle operationsare performed. In the detailed illustration of FIG. 6, the swage dialassembly 150 includes a swage plate 110 having four multi-axis gripperstations 145a, 145b, 145c, 145d spaced equally thereon. The swage plate110 is rotatably mounted at a central hub 109 and operable to rotateunder the control of a control system computer 99. In the preferredembodiment, a reciprocating carriage is provided at each multi-axisgripper station of the swage dial assembly 150. For instance, as shownin FIG. 16, multi-axis gripper station 145a includes reciprocatingcarriage 151a, while station 145b includes reciprocating carriage 151b,station 145c includes reciprocating carriage 151c, and station 145dincludes reciprocating carriage 151d. Mounted to each reciprocatingcarriage 151a,b,c,d for retractable movement therewith, are multi-axisgrippers, one of which 155 is shown connected to gripper mount 150c inFIG. 6.

As previously mentioned, each reciprocating carriage 151a,b,c,d and themulti-axis gripper 155 connected thereto is movable from a retractedposition to an extended position. When the gripper 155 is in theretracted position shown in FIG. 7(a), the needle 9 may be conveyed to adifferent station as the swage dial rotates; when the gripper 155 is inthe extended position as shown in FIG. 7(b), the needle is in one of theactive stations, such as the automatic swaging station. The swagingstation and the automatic pull-test station are both described infurther detail in respective copending patent applications 08/181,599,(attorney docket No. 8937) and 08/181,601 (attorney docket No. 8923)assigned to the same assignee of the present invention.

The process for extending the multi-axis grippers 155 for sutureinsertion will now be explained. As shown in FIGS. 7(a) and 7(b), eachcam follower 165a(b,c,d) is mounted to a cam slide 164 at one end of thereciprocating carriage 151, and the multi-axis gripper 155 is connectedto the cam slide 164 at the other end. Cam slide 164 is slidable withinstationary guides 166,167 and is adapted for reciprocal movement whenthe cam follower 165 is actuated. In the preferred embodiment shown inFIG. 8(a), cam follower 165 is a roller that fits within cam tracks of arotatable cam dial assembly 120. Cam dial assembly 120 is shown in FIG.8(a) as comprising a cam dial plate 125 having four cam tracks 160a,b,c,and 160d which correspond to a multi-axis gripper stations 145a,b,c, and145d, respectively. Each cam follower 165 is positioned within eachrespective cam track at each station for movement therein. For instance,as shown in FIG. 9, cam follower 165a is positioned within cam track160a and cam follower 165c is positioned within cam track 160c. Also inFIG. 9, cam dial 125 is positioned above swage dial 110 and mountedcoaxial therewith. The cam dial 125 is rotatable about a central shaft199 and controlled by a separate rotary indexing transmission (notshown) so that it may rotate separately from the swage dial plate 110.

FIG. 8(a) shows cam follower 165a in a first retracted position withinthe cam track 160a. When in this position, reciprocating carriage andconsequently multi-axis gripper 155 are in their retracted position asshown in FIG. 7(a) discussed above. To extend the multi-axis gripper 155in place at its respective station, the cam dial plate 125 is rotated inthe clockwise direction with respect to the swage dial plate 110, asindicated by the arrow in FIG. 8(a), for approximately 45-55 degrees,forcing cam follower 165a in its cam track 160a to move toward theperiphery of the dial as shown in FIG. 8(b). Consequently, the cam slide164, reciprocating carriage 151a, and the multi-axis gripper 155 move tothe extended position as shown in FIG. 7(b) and discussed above. To moveback to its retracted position, the cam dial plate 125 is rotated in thecounter clockwise direction with respect to the swage dial plate 110 forapproximately 45-55 degrees, forcing cam follower 165a in its respectivecam track 160a to move back to its retracted position (FIG. 8(a)).Consequently, the cam slide 164, reciprocating carriage 151a, and themulti-axis gripper 155 move to the retracted position as shown in FIG.7(a) and discussed above.

It should be understood that when cam dial plate 125 rotates withrespect to swage dial 110, each multi-axis gripper 155 is eitherextended or retracted in its respective cam track. Thus, the system isdesigned so that all processes performed at each station occursimultaneously and for approximately the same duration of time when themulti-axis grippers are in their extended position, for e.g., for needlepick-up, for needle swaging, or, for needle pull-testing. The timing ofthe system is operated under the control system, a detailed descriptionof which can be found in copending patent application 08/181,607(attorney docket No. 8927), assigned to the same assignee of the presentinvention.

When the multi-axis gripper 155 is retracted, the needle engaged therebymay then be indexed to a different station for further processing. Toindex the needle to another station, both swage dial plate 110 and camdial plate 125 are rotated together for approximately 90 degrees toposition each multi-axis gripper at the next station. For example, whenthe cam dial plate 125 and the swage dial plate 110 are simultaneouslyrotated 90 degrees counterclockwise in FIG. 1, the gripper 155 that hadreceived the needle at station 100 is now indexed to the positioncorresponding to station 200 for swaging a suture thereto. Similarly,after swaging, the cam dial plate 125 and the swage dial plate 110 aresimultaneously rotated counterclockwise so that the armed needle atstation 200 is indexed to the pull testing station 300 for pull-testingthereof. The operations performed concurrently at each station about theswage dial increases throughput to provide an output of pull-testedarmed surgical needles at a rate of approximately 60 per minute in thepreferred embodiment.

Automatic Swaging Station

As previously mentioned, the automatic swaging station 200 of the needlethreading and swaging system 10 is where the suture of indefinite lengthis drawn, cut, and inserted within the suture receiving end of asurgical needle for swaging thereof.

At step 19 of FIG. 3(a) the indefinite length of suture material isloaded at one end of the payoff assembly. In the preferred embodiment,the payoff assembly is embodied as a drawing tower 220 shown in FIG.12(a). The drawing tower 220 comprises left side rail 222 and right siderail 224 both mounted on suitable mounting block 225 and defining adrawing bed for drawing an indefinite length of suture material along adrawing axis therebetween. Located parallel to the left and right siderails 222,224 and suitably connected thereto are respective left guiderod 226 and right guide rod 228. The first gripper means or rightgripper 232 reciprocates up and down along right guide rod 228 while thesecond gripper means or left gripper 230 reciprocates up and down theleft guide rod 226. Each of the grippers 230,232 grip the suturematerial that is fed from a spool through pulley 235 located at thebottom of the drawing tower 220, and carries the material to the upperend of the tower. The right gripper 232 is mounted on right grippercarrier 233 for vertical movement along right guide rod 228, and theleft gripper 230 is mounted on left gripper carrier 231 for verticalmovement along left guide rod 226 as shown in FIG. 12(a). FIG. 11illustrates a gripper 232 (and 230) having a gripper arm drive 261 thatis pneumatically operated to drive pair of retractable gripper arms265a, 265b toward each other to a suture gripping position, or, awayfrom each other to an open position. Each retractable gripper arm isprovided with a non-metallic pad 266a, 266b for gripping the suturematerial 255 at a free end thereof when actuated to the grippingposition. To release the grip of the suture, gripper arms 265a,265b areretracted approximately 180 degrees apart in the direction indicated bythe arrows of FIG. 11 to the open position. When in the open positionthe gripper arms 265a', 265b' do not interfere with the motion of theother vertically moving gripper as it reciprocates along the respectiveleft or right rod, nor will it interfere with the cutter assembly 280that cuts the strand to a predetermined length as will be explainedbelow in view of FIG. 14. The retractable nature of the grippers and ofthe cutting assembly enables single drawing axis operation.

As mentioned above, each gripper carrier and gripper thereof is designedto advance vertically along the respective left and right rods. As shownin FIG. 12(a), the right gripper 232 and gripper carrier 233 is drivenby right servo motor 238 which is mounted to the right side rail 224 byright motor mounting bracket 239. Similarly, the left gripper 230 andgripper carrier 231 is driven by left servo motor 236 which is mountedto the left side rail 222 by left motor mounting bracket 237. In thepreferred embodiment, both left and right servo motors are interfacedwith and controlled by the control system computer 99. As shown in FIG.12(a), right servo motor 238 drives timing belt 243 which consequentlyenables vertical positioning of right gripper carrier 233 along rightrod 228, while the left servo motor 236 drives timing belt 241 whichconsequently enables vertical positioning of left gripper carrier 231along left rod 226. As FIG. 11 illustrates, timing belt 243 is clampedto its respective gripper carrier 233 by a timing belt clamp 268 locatedon the back of the gripper carrier. A similar timing belt clamp (notshown) is provided on gripper carrier 231 for clamping timing belt 241to enable vertical movement of gripper 230. FIG. 12(a) shows timing belt241 engaging upper left pulley 245 and lower left pulley 246 as well asidler pulleys 247,248 which are part of tensioner block 244 that adjuststhe tension of the timing belt 241 and consequently of left grippercarrier 231. Likewise, FIG. 12(a) shows timing belt 243 engaging upperright pulley 251 and lower left pulley 252 as well as idler pulleys253,254 which are part of tensioner block 245 that adjusts the tensionof the timing belt 243 and consequently of right gripper carrier 233.

FIG. 12(a) shows the tip and cut carrier 180 positioned along shafts 204and 205 which are located parallel to respective left and right rods226,228. Tip and cut carrier 180 provides the support for tippingassembly 290 that applies heat to a specific location of the suturematerial, and also provides support for the cutter assembly 280 thatcuts the suture material. In the preferred embodiment, vertical movementof the tip and cut carrier 180 is accomplished by cranking handwheel 208shown in FIG. 12(b). Other embodiments may implement a computercontrolled servo motor to vertically register the tip and cut carrier180 prior to cutting the material.

As illustrated in FIG. 12(b), cranking handwheel 208 actuates a gearbox213 that rotates chain drive sprocket 214. The gearbox 213 is mounted ona gearbox mounting bracket 122 which, in turn, is mounted to framemember 299. A cable chain 215 is engaged with chain drive sprocket 214to actuate movement of the tip and cut carrier 180 as shown in FIG.12(b). The cable chain 215 also engages chain idler sprockets 218 and219 which are rotatably mounted to upper tensioner pulley bracket 221and lower tensioner pulley bracket 223, respectively. The verticalpositioning of tensioner pulley brackets 221,223 may be adjusted to varythe slack in cable chain 215. Cable chain 215 also engages chain idlersprockets 227 and 229 which are suitably mounted on left side rail 222.As shown in FIG. 12(a), the back 211 of tip and cut carrier 180 isclamped to cable chain 215.

Both the stroke of the grippers 230,232 and the positioning of the tipand cut carrier 180 along drawing tower 220 dictates the length of thematerial that will be cut. For instance, as shown in FIG. 12(a),proximity sensors 273,274, and 275 are positioned vertically atdifferent heights along the drawing tower 220 to enable predeterminationof the length of suture material to be cut. Specifically, the locationsof the proximity sensors 273,274, and 275 sense the positioning of thetip and cut assembly 180 as controlled by handcrank 208 in order tonotify the control system 99 to change the reciprocating travel ofgrippers 230,232. Also as shown in FIG. 12(a), proximity sensor 270 ismounted at a position along the right side rail 224 to verify that rightgripper 232 has reached a desired position at the upper end of the tower220 and notify the control system 99 accordingly. Likewise, a proximitysensor (not shown) is mounted at the desired height along the left siderail 222 to verify that left gripper 230 has reached its desiredposition at the upper end of the drawing tower 220.

To feed the indefinite length suture material up the length of thedrawing tower, the suture material 255 is first manually threadedthrough eyelet 256 and through optional knot detector 257 which sensesany sudden change in the thickness of the suture material as shown inFIG. 13. Detection of a knot in suture material 255 will trigger thecontrol system 99 to discard the cut strand of material at a subsequentoperation. Additionally, the suture material may be threaded within atensioning (or dancer) assembly 259 which comprises a plurality ofvertically spaced apart cones 223 each of which may be positionedlaterally to increase or decrease the tension of the suture strand 255as shown generally in FIG. 13.

The suture material 255 is then advanced over pulleys 235a and 235blocated at the bottom of the drawing tower 220, and around pulley 212which is mounted on the lower portion of tip and cut carrier 180 that isillustrated near the center of the tower as shown in FIG. 12(a). Notethat the lower threading pulley 235b, guide pulley 212, left gripper 230and right gripper 232 are vertically aligned so that the cutter assembly280 will always cut horizontally across the strand of material as willbe discussed in detail below.

Under the control of the control system computer 99, the right servomotor 238 is enabled to drive the lead (right) gripper vertically alongright rod 228 to register the tip of the indefinite length suture strand255 for positioning within the suture receiving opening 7 of a preciselyoriented surgical needle shown engaged by the multi-axis gripper 155 atthe swaging assembly 390 located at the top of the drawing tower 220 asshown in FIG. 12(a). To accomplish this, the lead gripper servomotoradvances the lead gripper for a long stroke distance, which may rangefrom 12 inches to 36 inches depending upon the length of said suturestrand desired, but is 16.1 inches in the preferred embodiment. The longstroke moves gripper 232 from a home position just above the tip and cutcarrier 180 and below the cutter assembly 280, to the position slightlybelow swaging assembly 390 as shown in FIG. 12(a).

Simultaneous with the positioning of the lead gripper 232 during thelong stroke, the other servomotor, for e.g., servomotor 236, positionsthe bottom gripper, for e.g., left gripper 230, along left rod 226 atthe home position preferably above the tip and cut carrier 180 and belowthe position of the cutter assembly 280 as shown in FIG. 12(a). It isunderstood that the lead gripper is gripping the material 255 at alltimes during the long stroke, while the bottom gripper is in its openposition and not gripping. The process of advancing suture material 255by alternating grippers at each cycle eliminates the recycle or returntime for retaining the gripper to the original position. This makesfaster machine speeds and hence, higher production rates possible.

To insert the tipped end 258 of the suture material within the suturereceiving end 7 of surgical needle 9, the lead gripper 232 againadvances the suture material 255 for a short stroke distance of about1.9 inches, so that the tipped end 258 will advance precisely within thesuture receiving opening 7 of needle 9 for a swaging operation to takeplace at the swaging assembly 390.

As the tipped end 258 of the suture material is advanced during theshort stroke distance, a portion of the material 255 that has beenheated by tipping assembly 290, (explained hereinbelow), advancesvertically to a position just above the home position of the leftgripper 230 and adjacent the cutter assembly 280. Then, as automaticswaging of the tipped end 258 to the surgical needle occurs, the leftgripper 230 (lower gripper) is actuated to grip the material 255 at orbelow the tipped portion 278 i.e., the portion of the suture materialheated by tipping assembly 290 as shown in FIG. 12(a), and the cutterassembly 280 is actuated to cut the tipped portion 278 of the suturematerial 255 so that the left gripper 230 is now gripping an indefinitelength suture strand 255 having a tipped end 258. Simultaneous with theengagement of left or bottom gripper 230, the top or right gripper 232is actuated to release its grip on the definite length suture material.

Heater Assembly

Immediately after advancing the long stroke distance and prior toadvancing the short-stroke distance, the top gripper is temporarilyhalted so that a portion of the suture material 255 may be heated(tipped). Heating of the suture under tension and the subsequent coolingthereof will stiffen the material and aid in the positioning andsubsequent swaging of the tip of the material within the confines of thesurgical needle. The operation of the tipping assembly 290 mounted ontip and cut carrier 180 will now be explained as follows:

As shown in FIG. 18, the tipping assembly 290 is essentially an ovencomprising a heat exchanger unit 295 that heats the air in the heatercavity 296. When a pulse of incoming air is provided to the heatexchanger input 297, the heated air is displaced and it provides a pulseof heated air to a vertical cylindrical cavity 291 as shown in FIG.12(a). As shown in FIG. 18 the heated air is forced through horizontalorifice 294 for a predetermined duration so that the length of suturematerial 255 suspended in tension through vertical cavity 291 will beheated. The control system computer 99 controls the duration of the heatpulse so that the material is adequately heated and will have sufficienttime to cool before the cutting operation. Preferably, the temperatureof the heated pulse may vary depending upon the surface area of thestrand suspended through the vertical cavity 291. Preferably, thetipping assembly 290 is positioned slightly below the bottom or leftgripper 230. As mentioned above, this is required so that when thesuture material 255 is advanced the short stroke distance, the tippedportion 278 of material 255 will advance a corresponding distance sothat it may be cut by cutter assembly 280. This ensures that the bottomgripper, e.g., left gripper 230, will grip the material having a newtipped end 258 for the next suture draw/insert cycle.

It should be understood that various other "tipping" technologies willwork depending upon the type of suture material that is being processed.For instance, when VICRYL® and VICRYL®-like suture materials are used,tensioning of the strand, in addition to hot air application to a strandwill enable the surface thereof to be melt and recast to form astiffened tip. The application of tension in addition to a heated,grooved, die for forming the tip diameter of VICRYL® suture materialsmay also be used; however, the use of a die to form the tip diameter,requires closer control of the strand location to ensure that a tip getsinto the die groove for every cycle. For wax-impregnated suturematerials like silk, the application of tension only at predeterminedlocations, will form a stiffened portion of the suture strand at thoselocations. Another tipping method for use with braided suture materials,involves applying and penetrating the braid with a dilute resin materialsuch as General Electric's VITEL® having a high solvent content, andquick drying the applied portions with hot air while maintaining tensionof the suture strand materials to form a stiffened tip thereof.

Cutter Assembly

FIGS. 16-17(b) illustrate in detail the cutter assembly 280 which issuitably mounted to the tip and cut assembly 180 as shown in FIG. 12(a).As shown in FIG. 16, the cutter assembly comprises overcenter linkage282 having a link arm 283 pivotally connected at one end thereof. Apivotal locator arm 285 is fixedly connected to link arm 283 at a secondend thereof and is illustrated in FIG. 24 as substantially transversethereto. The other end of locator arm 285 is pivotally connected to astationary guide mechanism 286. Note, that all pivotal linkagesdescribed herein are simple pin linkages, the actuation of which createsthe dwell moment for cutting the suture strand and obviates the need forcomplicated cam, slots, and sliding mechanisms.

As shown in FIG. 17(a), the stationary guide 286 is located in a planeperpendicular to the drawing axis of the suspended strand of material255, and is located a distance from the strand approximately equivalentto the length of locator arm 285. In addition, overcenter linkage 282,locator arm 285, and cutting blade 289 all lie in planes perpendicularto the drawing axis of the strand of material 255.

A retractable ball slide 288 is mounted on the stationary guide 286 andcoupled to overcenter linkage 282 for moving the overcenter linkage andblade 289 along the stationary guide 286 in the direction indicated byarrow "A" in FIG. 16 from a cutting position to a retracted positionshown in FIG. 17(a). As the ball slide 288 moves overcenter linkage 282to a retracted position, the locator arm 285 is pivoted away from thestrand 255 and the blade 289 is retracted. Thus, when the cutterassembly 280 is in the retracted position prior to cutting of the strandand immediately thereafter, the blade 289 and locator arm 285 do notinterfere with the reciprocating motion of the grippers 232,230 alongthe drawing tower 220, nor do they come in contact with the suspendedstrand 255. In the preferred embodiment, pneumatic air cylinder 281enables reciprocating movement of the ball slide 288 along stationaryguide 286 as shown in FIG. 16.

When cutting the strand of material 255, the retractable ball slide 288reciprocates in the direction toward the strand 255 indicated by arrow"B" in FIG. 17(a) to bring the overcenter linkage 282, cutting blade 289and locator arm 285 to the cutting position shown in FIG. 17(b). As theovercenter linkage 282 moves to the cutting position, the link arm 283translates the movement of the ball slide 288 into pivotal movement ofthe locator arm 285. Locator arm 285 is provided with a V-shaped supportnotch 287 which functions to engage and position the strand of material255 to be cut as the arm is pivoted into the cutting position. TheV-shaped notch also functions to support the strand on two sides of thestrand 55 while it is being horizontally cut on a third side. Thisenables clean, broom-free cuts especially of multi-filament suturematerial, which has a tendency to form a broom end when the strand isunder tension and is cut by scissors, or, when the multi-filament strandis sliced and otherwise, not properly supported.

The cutting blade 289 of cutter assembly 280 is fixedly mounted toreciprocating ball slide 288 at a slight angle relative thereto and in aplane parallel with that of the locator arm 285. In the preferredembodiment, a single action by the pneumatic air cylinder 281 willenable movement of the reciprocating ball slide 288 along stationaryguide 286. This consequently enables pivoting of locator arm 285 fromits retracted position (FIG. 17(a)), so that V-shaped notch 287 supportsthe strand 255 at two sides thereof while a third side of the strandbears upon the cutting edge of blade 289 as the blade moves towards thesupported strand 255 traversing the drawing axis thereof. Thus, thestrand 255 is cut in a dwell moment of the locator arm after the locatorarm 285 has pivoted in the direction toward the blade 289 to the cuttingposition shown in FIG. 17(b). The blade 289 slices the strand ofmaterial while it is held stationary by locator arm 285 by virtue of theangled orientation of the blade with respect to the axis ofreciprocation illustrated in FIGS. 17(a) and 17(b). In the preferredembodiment, the slice ratio is 1:1, with the blade 289 angled atapproximately 45 degrees relative to the axis of reciprocation, so thatthe strand 255 is cut an amount equivalent to the distance the blade 289traverses the drawing axis.

Swaging Assembly

The swaging operation taking place at the swaging station will now bedescribed. FIGS. 14(a) 14(g) illustrate the multi-axis needle gripper155 and swaging and suture alignment dies shown in various stages of thesuture insertion and needle swaging sequence. This sequence, and theinteraction of the dies in relation to each other, the needle, and theinsertion of the suture, accomplish the insert and swage function withminimal parts and simple motions.

After conveying the needle to swaging assembly 390 shown in FIGS. 12 and13(a), the multi-axis gripper 155 is radially extended from the swagedial in the manner described above to position the suture receiving end7 of needle 9 between the funnel shaped die opening formed at the endsof two swage dies 361,369 as shown in FIG. 14(a) and the partialperspective view of FIG. 14(b). As will be explained, swage die 361 isfixed in position and swage die 369 is movable laterally toward thefixed swage die 361, as indicated by the arrow, to accomplish swaging ofthe suture receiving end of a needle placed therebetween. A funnelshaped die opening 392 having an exit diameter slightly larger than thediameter of the suture receiving end 7 of the needle is formed when thetwo swage dies 361,363 are positioned adjacent each other as shown inFIGS. 14(e) through 14(f). In the preferred embodiment shown in FIGS.19(a) and 19(b), the ends of each of the swage dies 361,369 are providedwith recesses 321,322 respectively, so that the metal deformation thatoccurs as a result of the swaging of the needle 9, does not result inmetal flash or spurs at the suture receiving end 7 of the needle. Notethat different sets of swage dies may be provided, depending upon thesize (diameters) of the needles and sutures to be swaged.

To precisely position the suture receiving end 7 of needle 9 between theswage die opening 392 formed at the ends of two swaging dies 361,369,the movable swage die 369 is temporarily moved apart. In theillustration of the swaging assembly 390 shown in FIG. 15(a), swage die369 is moved apart from the fixed swage die 361 by actuating aircylinder 395 to provide a force upon cylinder rod 393 to enable swagedie operating lever 397 to pivot about screw 394 and pull moveable swagedie 368 a predetermined distance away from the fixed swage die 361. Inthe preferred embodiment, lever 397 is biased by spring 364 so that themovable swage die 369 will return toward the fixed swage die by thespring restoring force when the pressure provided by the air cylinder395 is terminated.

FIG. 14(c) shows die 361 in its fixed position, and moveable die 369 inits spaced apart position prior to receiving the surgical needle 9presented by multi-axis gripper 155. Suture alignment die 362,containing suture guide funnel half 362b, is positioned under swage die361, and free to slide laterally within limits. Alignment die 362 has atang 362a that protrudes into cavity 361a formed within swage die 420.Compression spring 361c bears against the back wall of cavity 361a andtang 362a such that funnel die 362 slides forward until it isconstrained by cavity wall 361b. In this position, it is forward of thecenter axis defined by the suture receiving end of the needle, andserves as a shelf 362c that helps assure suture receiving end 7 ofneedle 9 is in position for swaging. In this stage of the cycle, theparts are not positioned for suture insertion, and suture clamp 265agripping suture 255 and stiffened end 258, are in dwell. Suturealignment die 368, containing funnel half 363, is fastened to swage die369 by suitable fastening means, described in detail below, and travelswith it to the open position shown.

While the swage dies are apart, the multi-axis gripper 155 is extendedto position the suture receiving end 7 of needle 9 within the opening392 as shown in FIG. 14(c) and FIG. 15(a). After positioning the suturereceiving opening 7 of needle 9 at the swage die opening 392, the swagedie 369, and suture alignment die 368, are moved toward needle 9 withthe resilient spring force present in spring 364 (FIG. 15(a)) that issufficient to enable the die 369 to grip and locate the suture receivingend 7 precisely against fixed swage die 361 without deforming the cavityof the suture receiving opening 7 formed therein. Concurrently, needleretaining pin 142 in multi-axis gripper 155 is raised by downwardexternal force on plunger 149, as described above, thereby releasing theneedle so that its position is determined by the grip of swaging dies361 and 369. The motion of dies 368 and 369 cause the face 368a ofsuture alignment die 368 to come in contact with the corresponding face362c of suture alignment die 362. The resilient force causing thismotion is forceful enough to compress spring 361c, and move funnel die362 to the left, such that tang 362a is no longer in contact with cavitywall 361b. Dimensioning of dies 369 and 368 is such that this motionresults in the formation of two funnel halves 362b and 363 defining asmooth conical shape that is coaxial with the suture receiving end 7 ofneedle 9. FIG. 14(d) shows the suture receiving end 7 being gripped bythe swage dies 361,369 prior to suture insertion. Note that the exitdiameter of the conically shaped funnel guide formed of funnel halves362b and 363 is preferably equal to or greater than the diameter of thesuture tipped end 258 and smaller than the diameter of the suturereceiving end 7 of the needle 9, as shown in FIG. 14(e), so that thetipped end 258 of the suture strand may be easily inserted therein.

FIG. 14(e) shows suture gripper 265a moved vertically to the insertionposition, which causes stiffened suture end 258 to enter funnel 362b and363, and be guided into the suture receiving cavity 7 of needle 9axially aligned therewith. Once the strand is inserted into the suturereceiving end 7 of the needle (step 28) as discussed above, theautomatic swaging of the suture receiving cavity occurs. In thepreferred embodiment of the swaging assembly 390 shown in FIG. 15(a), apneumatic air cylinder 365 provides air pressure to actuate cam 375 thatbears on lever 397 to thrust movable swage die 369 toward the fixedswage die to accomplish the swaging of the suture receiving end of theneedle placed therebetween. Air pressure is supplied to the swagecylinder 365 via ports 366,367 under the control of the control systemcomputer 99.

FIG. 14(f) shows the completed swage stroke. The swage die 369 has beendriven to a fixed stop by the swage cylinder, which exerted sufficientforce to deform the suture receiving end 7 of needle 9. As deformationtakes place, suture alignment die 368 further displaces funnel die 362,causing additional compression of spring 361c. In the preferredembodiment, the moveable swage die 369 comes to an automatic stop by aswage stop mechanism herein described.

As shown in FIG. 15(b), movable swage die 369 and suture alignment die368 are mechanically held coincident to each other by shouldered post369a, the smaller diameter of which is a light press fit into the matinghold in die 369. Cap screw 369c, with washer 369b retain the post in die369. The larger diameter of post 369a, below die 369, extends through alight press fit hole in funnel die 368, so that the right hand swage andfunnel dies are linked to move together laterally during the swagingcycle. The lower portion of shouldered post 369a extends through funneldie 368, into groove 390b, which is cross milled into swage assemblyframe 390a. When the swage stroke is performed, the swage cylinderdrives this die assembly to the left until it is positively stopped bythe lower portion of post 369a striking wall 390c of groove 390b. Thisstalls air cylinder 365, so that the stroke of the moveable right handdie assembly shown is always the same for repeating cycles of themachine.

In an alternative embodiment, both swage dies 361,369 may be movabletowards each other to accomplish swaging. Furthermore, an adjustableswage stop mechanism for changing the swage stroke distance of one ofthe movable dies may be provided to further control the swaging pressureapplied to the suture receiving opening and obviate the need for afine-tune positioning adjustment for a fixed swage die.

As shown in the top view of FIG. 15(a), a needle fence assembly 398 isprovided to ensure that the needle 39 does not tip or become misalignedwhen the end 37 of the relaxed needle is positioned between the swagedies. The needle fence assembly 398 comprises a needle fence plate 399whose distance from the tapered swage die opening 392 is adjustabledepending upon the size of the surgical needle to be swaged.

In the preferred embodiment, the degree of swage compression imparted onthe needle, and resulting strength of grip by the needle on the suture,is adjusted by precise positioning of the fixed die 361. As shown inFIG. 15(a), servomotor 345 drives pulley 344 via timing belt 461, whichrotates the swage adjust screw 347. The pitch of the swage adjust screw347 is selected to move sliding wedge 348 a small distance. The swagedie 361 has a complementary ramp angle 343 at the opposite end whichbears on the wedge 348 to retract or advance the position of the swagedie 361 a precise distance proportional to the movement of the slidingwedge. Thus, the rotation of the swage adjust screw 347 and motion ofthe sliding wedge 348, results in transverse movement of the swage die361 to thereby finely adjust its fixed position. For example, when alarger suture is to be swaged to a needle, the position of the fixed die361 may be moved further away from the suture drawing axis so as toprovide the desired amount of deformation when the swaging pressure isapplied to the needle by the movable swage die 369. In the preferredembodiment shown in FIG. 15(a), the control system computer 99 will sendthe appropriate signals to automatically direct the servomotor 345 toadjust the position of the swage adjust screw 347, and hence, theposition of the fixed die 361, in accordance with the pull-out testvalues of the needle-suture bond as measured by automatic pull-testsystem as explained in further detail below. Specifically, appropriatecontrol signals may be generated to direct the servomotor 345 to adjustthe rotational position of the swage adjust screw 347 in accordance withstored statistical results of the pull-testing occurring at thepull-test station. Automatic pull-testing of the armed needle isdesirable to ensure that the upstream swaging dies are optimallypositioned to avoid over-swaging the needle-suture bond and hence,preventing the likelihood of clip-off, and, to avoid under-swaging theneedle-suture bond to prevent the chance of pull-out.

Immediately after the short stroke of the right or top gripper 232, theleft gripper 230 secures the suture strand, and the suture material 255is cut by the cutter assembly 280 in the manner described above and asindicated in step 30 in FIG. 3(b). As shown in FIG. 12(a), the cutterassembly 280 is positioned slightly above the left gripper 230 so thatthe indefinite length suture strand 255 will be gripped When the swagedstrand is cut. Thus, the left gripper 230 is now gripping the suturematerial 255 with a tipped end 258 and it now becomes the lead gripper.

In the preferred embodiment shown in FIG. 12(a), a vacuum air flow isenergized to pull the strand of material 255 toward the nylon screen 357to facilitate the cutting of the material thereof. After cutting of theindefinite length suture material 255, the tail end of the length ofsuture material that had been swaged to the surgical needle is suckedinto a large vacuum pipe 358, that is connected to a vacuum assembly(not shown) by vacuum hose 359 as shown in FIG. 12(a). The vacuumcreated in vacuum pipe 358 exerts a mild tension in the strand ofmaterial to keep the tail end from entanglement or coming into contactwith the machinery. However, it is mild enough to allow the strand to bepulled out of the pipe 275 as the armed needle is indexed for furtherdownstream processes.

After swaging of the needle, the movable die 369 is again retracted byair cylinder 365 and the pin 142 of the multi-axis gripper 155 isactuated to engage the armed needle in the manner described above.Subsequently, the multi-axis gripper 155 is retracted (step 30) to itsposition along the swage dial 150 for subsequent indexing to thepull-test station 300 for further processing (step 31).

The cycle continues at the swaging station with the new lead grippervertically drawing the material 255 along the height of the drawingtower 220 to position the next strand to be cut for insertion within thesurgical needle. The process of advancing suture material 255 byalternating grippers at each cycle eliminates the recycle or return timefor retaining the gripper to the original position.

Automatic Pull-test Station

A test of the strength of the swaging bond of the armed needle indexedat the automatic pull-test station 300 may be performed as described indetail below and in further detail in copending patent application08/181,601 (attorney docket No. 8923) assigned to the same assignee ofthe present invention and incorporated by reference herein. Automaticpull-testing of the armed needle is desirable to ensure that suturepull-test requirements are met. Specifically, as described in detailbelow, either a minimum pull-test, indicated as step 32 in FIG. 3(b),or, a destructive pull-test, indicated as step 33 in FIG. 3(b) is beingperformed at the pull-test station 300.

The automatic pull-test assembly 300 for accomplishing automaticpull-testing of an armed surgical needle is shown generally in FIGS. 20through 21(c). The automatic pull-test assembly 300 generally comprisesa load cell mounting assembly 330 for mounting a load cell 335 whichfunctions to receive the armed needle 9 from the multi-axis gripper 155which is indexed thereto as shown in FIGS. 20 and 21(a). A needlerelease assembly 315 is provided for relaxing the armed needle from thegrip of the multi-axis gripper 155. Pull-test fence assembly 340 isprovided to prevent the armed needle 9 from tipping over or becomingmisaligned when the armed needle is relaxed. Suture gripping assembly370 containing retractable gripper arms 325a,b for gripping the suture255 during the pull-tests, and which are connected to the weighted slideblock assembly 372 for performing the pull-test is provided as shown inFIG. 20. A detailed description of each of these assemblies and theirinteraction will be explained in detail hereinbelow.

As shown in FIGS. 20 and 21(a), an armed surgical needle 9 is retainedby a multi-axis gripper 155 and, in the manner described above, isindexed to the automatic pull test station 300 by the rotary swage dial150 partially illustrated in the FIG. 20. To position the armed needle 9in the load cell 335, the multi-axis gripper is extended from the swagedial 150 so that the end portion 7 of needle 9 is positioned above acorresponding receiving blade 336 of the load cell 335 as shown in FIG.21(a).

FIG. 22 illustrates a top view of the load cell mounting assembly 330with load cell 335 mounted thereon. In the preferred embodiment, loadcell 335 has mounted thereon four (4) thin needle supporting blades336a,b,c,d for supporting the suture receiving end portion 7 of varioussize surgical needles with the suture material 255 depending therefrom.For instance, load cell needle supporting blade 336a labelled "1/0"accommodates a larger sutures having a diameter of approximately0.017+/-0.001 inches; load cell needle supporting blade 336b labelled"2/0" accommodates sutures having a diameter of approximately0.014+/-0.001 inches; load cell needle supporting blade 336c labelled"3/0" accommodates sutures having a diameter of approximately0.011+/-0.001 inches; and load cell needle supporting blade 336dlabelled 37 4/0" accommodates a smaller suture with a diameter ofapproximately 0.009+/-0.001 inches in the preferred embodiment.Depending upon the batch of surgical needles currently being pulltested, the appropriate needle supporting blade 336a,b,c,d will bepositioned to receive the needle from the multi-axis gripper. Knob 339located centrally on top of the load cell 335 may be manually operatedto rotate the load cell and position the correct sized suture receivingblade prior to carrying out automatic pull-testing. Additionally, theload cell 335 may be laterally positioned by moving slide handle 338 andconsequently load cell platter 337 towards or away from the sutureneedle indicated by the arrow in FIG. 22.

The multi-axis gripper 155 is initially positioned so that the endportion of armed needle 9 is supported by the appropriate needlesupporting blade 336 (e.g. blade 336b). FIG. 23 is a front crosssectional view illustrating the suture receiving end portion 7 of needle9 resting upon the needle supporting blade 336b with the suture strand255 threaded between the suture receiving guide 334.

Non-destructive pull testing of the armed surgical needle 9 isaccomplished as follows:

After positioning the multi-axis gripper as heretofore described,gripper arms 325a,b of suture gripping assembly 370 are extended from aretracted position to grip the suture strand 255 slightly below theneedle supporting blade 336 of load cell 335 as shown in FIG. 30. Agripper actuator 372a is provided for opening and closing gripper arms325a,b, as shown in FIG. 20, and is controlled by a control systemprogram resident in control system computer 99 as explained in furtherdetail in copending patent application 08/181,607 (attorney docket No.8927) assigned to the same assignee of the present invention. FIGS. 20and 21(a) illustrate the slide block assembly 372 that is composed ofslide rods 372b,c that are connected to a lower slide block 372d. Slideblock 372d includes a slide finger 372e upon which air cylinder pistonrods 374a and 379a, of respective air cylinders 374,379, applyrespective upward and downward forces depending upon the type ofpull-test that is to be performed. As shown in FIG. 21(a), piston rod374a is shown in an extended position providing an upward force thatsupports slide finger 372e and consequently maintains slide block 372dof slide assembly 372 at a fixed vertical position.

Slide block 372d is counterweighted to a net downward weight of 2 to 5ounces by appropriately sized counterweight 376 that acts through cable373, around pulley 377, and through attachment point 372h. Thiscounterweight 376 acts to pull upward on slide block 372d at theattachment point 372h.

To accomplish the non-destructive pull test, piston rod 374a of aircylinder 374, mounted on the mechanism frame 371 and controlled bysystem computer 99, is retracted from its extended position (FIG. 21(a))supporting the slide finger 372e as shown in dashed line in FIG. 21(b),by reversing its air supply (not shown), to the position shown in thefigure. The piston rod 374a is retracted to remove the upward force onslide finger 372e, as shown in the FIG. 21(b), to thereby impose thecounterbalanced net weight of 2 to 5 ounces of slide block 372d on theswage attachment means of suture 255 in needle 9, in the direction ofarrow "A". Accuracy of this system is enhanced because slide block 372d,suspended on slide rods 372b,c, are mounted in low friction ballbushings, 372f and 372g, that are pressed into slide mount 371, therebyimposing minimal mechanical drag on the-system.

Note in FIG. 20, that the slide block mount 371 is positioned parallelto the axis of the suture 255 depending from the needle 9, and islocated a distance away from the suture 255 corresponding to the lengthof the gripper arms 325a,b.

Simultaneous with or momentarily before the slide assembly 372 isreleased, the needle release assembly 315 is actuated to enablemulti-axis gripper 155 to disengage its grip on the armed needle 9.Releasing the armed needle from the grip of the gripper 155 is necessaryto ensure that it is firmly positioned on the load cell needlesupporting blade 336. Moreover, to provide an accurate pull-test, theneedle must be released so that there is no existing upward force thatwould cause false results.

As shown in FIG. 20, needle release assembly 315 comprises needlerelease solenoid 324 that is actuated to extend pusher 326 into pivotallever arm 327. Pivotal lever arm 327 pivots about pin 328 to depressplunger 149 of the multi-axis gripper 155 at one end 329 thereof. Asshown in FIG. 21(a), depressing plunger 149 enables pin 142 to retractwithin pin guide 147 to release the armed needle 9 engaged thereby.Further details of the operation of the multi-axis gripper 155 can befound in the above-mentioned copending patent application 08/181,599(attorney docket 8937).

To prevent the armed needle 9 from becoming misaligned or from tippingover after the multi-axis gripper 155 releases its grip on the needle, aneedle fence assembly 340 is provided. As shown in FIG. 20, the needlefence assembly 340 includes vertical fence plate 342 which can beadjusted to lie flush against the gripper 155 to retain the armed needlein an upright position. Adjusting the lateral positioning of thevertical fence plate 342 is accomplished by moving slide handle 343 foran appropriate distance as shown in FIG. 20. In the preferredembodiment, the configuration of the face of the vertical needle fenceplate 342 (not shown) may be changed to accommodate the configurationsof different size needles.

The controlled release of the minimum pull-test is of short duration,preferably ranging in milliseconds. If the test is successful, i.e., thesuture meets the minimum pull-test requirements, the needle isre-gripped by the multi-axis gripper 155 by deactuating the needlerelease solenoid 324 (FIG. 20) which releases the force on plunger 149.The suture grippers 325a,b are then retracted to their open position torelease their grip on the suture 255 as controlled by the controlsystem. Subsequently, the multi-axis gripper 155 is retracted and therotary swage dial is rotated to convey the armed needle downstream forfurther processing.

If the suture fails the minimum pull-test, i.e., if the suture 255 isdislodged from the surgical needle 9 as a result of the controlledrelease, the control system computer 99 is flagged so that the disarmedneedle 39 will be ejected at the pull-test station. The dislodged suturestrand 255 will be drawn into a vacuum assembly (not shown) and theneedle 9 will be ejected by a needle stripper assembly 380 showngenerally in FIG. 21(a) and in detail in FIG. 24. As shown in FIG. 24,needle stripper solenoid 382 will be actuated by a control signal outputfrom the control system computer 99 to extend needle stripper blade 385mounted on a slide block 383. The needle stripper blade 385 is shown inFIG. 20 located next to the needle 9. Thus, when the needle is in itsrelaxed state on the multi-axis gripper 155 and the minimum pull-testfails, the needle stripper blade 385 is extended to remove the needlefrom the gripper. The needle will fall and be collected by appropriatecollection means (not shown) located at the pull-test station.

To prepare for the next armed needle to be pull-tested, the slideassembly 372 and retracted gripper arms 325a,b are pushed back up theslide mount 371 to their unloaded position by an appropriate upwardforce supplied by the air cylinder 374 and piston rod 374a as controlledby the control system computer 99. At this time, another flag may besent for storage to the control system computer that indicates that thepull-test performed on the particular needle 9 was successful and thatthe armed needle may be conveyed downstream for packaging thereof.

In the preferred embodiment of the minimum and destructive pull-testsystems shown in FIGS. 20-23, the load cell 335 and the needle supportblades 336a,b,c,d thereof comprise a piezoelectric transducer thatmeasures the force applied by the suture gripping assembly to theneedle-suture assembly 9. The transducer load cell 335 may be interfacedwith the control system computer 99 by conventional means as shown inFIGS. 20 and 22, and, in the preferred embodiment, is a 1000 gramtransducer manufactured by Techniques Co. (Model No. GS-1K). The forcesapplied to the suture 9 and measured by the load cell transducer 335during the destructive pull-testing may be stored for statisticalpurposes or for real-time monitoring during a swage die setup routinethat may take place when a new batch of surgical needles are to beswaged. For instance, if the destructive pull-tests fail and the forcesmeasured by the transducer are determined to be at the low end of apredetermined range, then the control system computer 99 willacknowledge this and send appropriate signals to the upstream swagingassembly (not shown) causing a fixed swaging die to be advanced anincremental amount toward the moveable swage die, resulting insubsequent swages being stronger. Likewise, if the destructive pull-testpasses, i.e., the forces measured by the transducer are determined to beabove the minimum and below an upper limit, then no die adjustment needbe made.

As previously mentioned, the automatic pull-test assembly 300 is used toperform a minimum pull-test upon every armed surgical needle indexedthereto prior to automatic packaging thereof. A destructive pull-testingof the armed surgical needle is performed at every nth needle indexedthereto. The purpose of performing a destructive pull-test is to set theswage dies located at the upstream swaging station for correct maximumswage pull-out value. This is by necessity a destructive test, and thetest frequency, which is programmable, is set high enough to maintaincontrol of the operation, but low enough to avoid excessive productwaste. In the preferred embodiment, this frequency is set at every 50thneedle, but could be every 75th or 100th needle.

Another purpose of the destructive pull test is to aid in installing anew swage die set during a changeover procedure, which is a procedurethat is used to prepare the needle sorting and swaging apparatuses(swage dies) for processing a new batch of needles when they are of adifferent size from a previously processed batch. Contrary to thenon-destructive pull-test described above, the pull-test apparatus isprogrammed for 100% destructive test of a swaged needle, while theswaging assembly is operating and feeding the armed needles to thepull-test station. The die adjustment system at the upstream swagingassembly will receive a signal from the transducer load cell 335, ateach machine cycle, and quickly perform a correct adjustment of theswage dies.

Destructive test pull-out values are recorded in the system computer 99and are used to compute statistical process control information which isfed back to the machine operator through display screens.

Destructive pull testing of the armed surgical needle 9 is accomplishedsimilarly as described herein above with respect to the minimum pulltest. However, the fundamental difference is that a fixed mechanicalstroke that is great enough to pull the suture out of the needlereplaces the minimum 2 to 5 ounce force of the minimum pull test.

As shown in FIG. 21(c), piston rod 379a of second air cylinder 379located opposite air cylinder 374, is programmed to provide a fixedstroke against slide finger 372e from a non-actuating position shown inFIG. 21(a) to the position shown in FIG. 21(c). This results in thevertical displacement of slide finger 372e from a position shown by thedashed line to a position shown by the solid line. This further resultsin a downward force upon slide block 372d, which, through slide rods372b and c, moves slide assembly 372, including grippers 325a,b andsuture 255, in the direction of the arrow "B" as shown in FIG. 21(c).Air pressure to cylinder 379 is set high enough to always pull suture255 out of needle 9. This stroke is limited by the top portion 372j ofslide assembly 372 striking the top of stationary block 371.

The force necessary to accomplish the destructive pull-test is measuredby the piezoelectric load cell transducer 335 as discussed above. If itis determined by the process control algorithm (not shown) that thedestructive pull-test forces as measured by the transducer load cell arelower than a predetermined range of pull-test values, the control systemcomputer 90 will send out appropriate control signals to increase theswaging die stroke applied when swaging the suture to the needle at theupstream swaging station. If it is determined that the destructivepull-test forces as measured by the transducer load cell are higher thanthe predetermined range, the control system computer 99 will send outappropriate control signals to the upstream swaging assembly to move afixed swage die a small incremental distance away from the suture,thereby decreasing the swaging pressures applied when swaging the sutureto the needle.

Since the destructive pull-test necessarily results in the suture 255becoming dislodged from the needle 9, the needle 9 is again removed fromthe grip of the multi-axis gripper 155 by the needle stripper blade 385as described above. Subsequently, the gripper arms 325a,b are retractedto their open positions and air cylinder 374 provides the upward forceto restore the gripping assembly 370 and slide block assembly 372 backto their normal position in preparation for the next pull-test.

AUTOMATED PACKAGING MACHINE

During the process of arming surgical needles at the needle threadingand swaging dial 150, as described above, simultaneous packagingprocesses occur at the rotary suture wind and packaging turret 500. Inessence, the suture wind and packaging turret 500 is adapted to beindexed forwardly in the direction of arrow "B" shown in FIG. 1, suchthat each tool nest located on turret 500 is adapted to be advanced insuccession to a number of workstations located about its periphery.Further details of the automatic packaging system can be found incopending patent application 08/181,626 (attorney docket No. 8925)assigned to the same assignee of the present invention and incorporatedby reference herein.

The foregoing indexing motions of the rotary packaging turret 500 areimplemented in order to produce a completed suture package and arecorrelated with each other through the program-controlled operation ofthe machine such that the dwelling-time periods at each of therespective workstation is computed to allow sufficient time for thepreceding step to be completed at the preceding workstation orworkstations. This enables a smooth and continuous flow of product fromthe automated packaging machine and provide for high-speed and efficientmanufacturing cycles.

SUTURE WIND AND PACKAGE DIAL

As shown in FIGS. 25 and 26 the rotary suture wind and package turret500 is essentially constituted of a circular disc-shaped dial 514 havinga plurality of tool nests 516 located thereon in uniformly spacedcircumferential array on the upper surface 518 of the rotary packageturret 500, and with each tool nest extending radially outwardly of theperiphery thereof.

Generally, as shown in FIG. 25, there are provided eight tool nests 516arranged at 45° angular spacings from each other about the circumferenceof the dial 514. As shown in detail in FIGS. 26 through 28 of thedrawings, each tool nest 516 consists of a housing 520 which is fixedlymounted on the upper surface 518 of the disc-shaped dial 514 of rotarydial 500, and includes a portion 522 radially outwardly projecting fromthe circumferential edge 524 of the disc member 514 which is operativeto receive and support flat-bottomed injection-molded plastic traysutilized in the forming of suture packages containing surgical needlesand attached sutures, as described hereinbelow.

As illustrated in FIGS. 26 through 28(a), each of the tool nests 516comprises a housing or block 520 fixedly mounted through suitablefasteners to the upper turret surface 518 proximate the peripheral outerrim or edge 524 of the dial 514 of turret 500. Each housing 520 includesa horizontal radially extending central bore 526 having a shaft 528supported on bearings 529a and 529b rotatably journaled therein, withthe shaft being connected to a suitable drive source (as subsequentlydescribed). Cam rollers 530 mounted at the radially inner end 532 of thehousing 520 are adapted to contact a cam plate dial 533 extending overthe dial surface 518 during the rotation of the turret 500 for purposesas described in more specific detail hereinbelow. At the radially outerend 534 of the housing 520, there is provided structure for supportingthe components for forming a suture package, the latter initiallycomprising a generally flat injection-molded tray 420 for receiving andretaining therein a plurality of surgical needles and attached sutures;for example, as illustrated in FIG. 46 of the drawings, and with anapplied tray 420 cover as shown in FIG. 47, as disclosed in a U.S. Pat.No. 5,230,424 entitled "Multi-Strand Suture Package and Cover-Latching",commonly assigned to the assignee of the present application; thedisclosure of which is incorporated herein by reference.

The radially outer structure of the housing 520 for initially mountingthe plastic suture tray 420 includes a generally rectangular,round-cornered and vertically extending plate member 536 of which theouter peripheral surface 538 forms a cam surface, employed for asuture-winding purpose as described hereinbelow, and with the platemember 536 being secured to the radially outer end of the shaft 528 forrotation therewith. Mounted on the front surface of cam plate member 536is a plate 540 having a radially outwardly facing, vertically-orientedsupport surface or platform 542 possessing projecting guide pins 544 forthe positioning and mounting thereon of an injection-molded plastic tray420 adapted to be supplied with surgical needles and attached sutures.The cam plate member 536 and the plate 540 for supporting the suturetray 420 are connected with each other so as to be secured againstrelative rotation, both being jointly rotatable about the longitudinalhorizontal axis 528a of the shaft 528 extending through the block orhousing 520. However, the plate 540 for mounting the tray 420 islinearly displaceable relative to the cam plate member 536 through theprovision of cooperating slide guides 546 located between theseelements. These slide guides 546 are disclosed in more extensive detailin the enlarged fragmentary illustration of FIG. 28(b), where they areillustrated as mating guide rails 546a and 546b, and are provided tofacilitate the successive insertion of an array of surgical needles intothe tray 420 which is mounted on the guide pins 544 extending from thesupport surface 542 of the plate 540 of the tool nest 516.

The external configuration of both the cam plate member 536, i.e. itscamming surface 538, and the support plate 540 is substantially inconformance with the outer shape of the suture tray, although larger inexternal dimensions than the latter.

(1) Generally, the first of the successive workstations located aboutthe rotary suture wind and package turret 500, as is the package loadstation 400. As indicated at step 40 of FIG. 3(c), empty suture trays420 are positioned on the radially outwardly facing platform or supportsurface 542 of the plate 540 on tool nest 516, and retained thereon bymeans of the guide pins 544 extending through positioning apertures inthe tray 420 so as to be in a generally vertical orientation relative tothe horizontal plane of rotation of the rotary dial 514. Suitablegrippers of a tray 420 feeding apparatus or mechanism (not shown) may beprovided to supply empty trays to successive plates 540 and position thetray 420 thereon. The grippers may obtain individual tray 420 from asuitable supply source, such as a stack of trays, and position the tray420 one each on successive forwardly indexed platforms 540 of the toolnests 516. Alternatively, in the absence of gripper mechanisms the tray420 may optionally be manually positioned on the guide pins 544 ofplatform 540 such that the rear surface of each tray 420 contacts thesupport surface or platform in a flat, surface-contacting relationshipso as to be firmly mounted thereon.

In summation, at the package load workstation 400, the support surfaceor platform 542 on the plate 540 for receiving an empty injection-moldedplastic tray 420 is indexed by rotary dial 514 into alignment with atray dispensing mechanism from which a tray is gripped and removed froma stack of trays and pivoted into alignment with platform 542 andadvanced thereon so as to cause the apertures in the tray to bepositioned in registration on the guide pins 544 projecting from theplatform 542. Thereupon, the tray dispensing mechanism is withdrawn, andplaced into position to receive a successive tray which, when thefirst-mentioned tray is indexed forwardly by the rotary dial 514 to thenext workstation, will enable a further tray to be mounted on asuccessive platform on a tool nest 516 located on the. rotary dial 514.At that time, the vertically extending plate 540 with platform 542 andthe cam plate 536 on which it is arranged are oriented in a manner withthe side edges thereof vertically extending, as shown in FIGS. 26through 28(b) of the drawings. Alternatively, if desired, this procedureof positioning a tray on the platform 542 may be manually implemented,thereby eliminating the foregoing operative structure.

Upon the withdrawal of the dispensing mechanism which positioned theempty tray 420 on the support platform 542, the rotary dial 514 is nowin a condition to be indexed or rotationally advanced forwardly to thenext workstation, in the direction of arrow "A" of FIG. 25.

(2) The second of the successive workstations located about the rotarysuture wind and package turret 500, and, which may be optional on themachine, is the package detection station 450. The package or tray420-detecting workstation 450, as shown in FIGS. 29 and 30, includes asuitable sensor 551 which is mounted on the arm of a stationary bracketarrangement 552 to provide assurance that a tray 420 has actually beenphysically positioned on the support surface or platform 542, andretained thereon by means of the guide pins 544 projecting radiallyoutwardly through the apertures in the tray 420. This is indicated asstep 43 in FIG. 3(c). Specifically, sensor 551 is interfaced with andadapted to provide this information to the control system 99 for thepackaging machine as to the required presence of a tray 420 in order toenable subsequent packaging steps to be implemented by the packagingmachine responsive thereto.

In summation, this particular workstation, which is essentiallyoptional, has the sensor 551 positioned in front of the rotary dial 514,such that upon the platform 542 on the rotary turret mounting a traybeing positioned in indexed alignment with the sensor, the latter mayascertain the presence of a tray 420 and its appropriate support on theguide pins 544 of the support platform 542. Upon a determination havingbeen transmitted by the sensor to that effect to the operating and drivecomponents (not shown) of the machine, the indexing rotary dial 514 isnow in a condition to advance the tray on its support platform 542 tothe next workstation, as indicated as step 45 in FIG. 3(c).

Needle-Suture Load to Package Station

(3) The third workstation 600 (as indicated in FIG. 25) indexed in thedirection of arrow "A" shown in FIG. 25 utilizes the multi-axis gripper155 of the rotary swage dial 150 for inserting a specified number ofsurgical needles and attached sutures into the suture tray 420 indexedby the packaging dial 500 in a confrontingly opposed relation with themulti-axis gripper. The needles are fed by the multi-axis gripper 155 soas to be positioned on a suitable clamping structure constituting anintegral portion of the suture package tray 420, such as raisedcomponents molded on the central bottom surface portion thereof, asshown in FIG. 46 of the drawings. A more detailed description may befound in copending patent application 08/181,598 (attorney docket No.8922) assigned to the same assignee of the present invention andincorporated by reference herein.

Generally, the plate 540 and its support platform 542 mounting the trayon the guide pins 544 is indexed incrementally vertically, such as inupwardly spaced steps, along a relative displacement between elements546a and 546b of the slide guides 546, and resultingly between the camplate member 536 and plate 540, to ensure that the appropriate number ofneedles are positioned therein by multi-axis gripper 155 at theirintended arrayed locations in the tray. This needle feeding action isfacilitated through the program-controlled vertical incrementaldisplacement between the plate 540 having the tray-supporting platform542 thereon and the cam plate member 536 by the relative slidingmovement taking place therebetween.

At the needle-suture load to package station 600, the each multi,axisgripper 155 of the rotary swage dial 150 successively positions andparks needles in the needle clamping structure formed in the centerportion of the tray 420, as illustrated in FIG. 46 of the drawings.

As is illustrated FIG. 31, an empty tray 420 has been previously mountedon a tool nest 516 of the main rotary turret 500. The tool nest 516includes the plate 540 having the tray-supporting platform 542 which maybe registered in increments so that the empty tray 420 may receive eight(8) armed needles. While the preferred embodiment described hereindescribes the invention with respect to a reduced size organizer package(RSO) which is adapted to be supplied with eight (8) needles, it shouldbe understood that the invention could be used with equal efficiencywith a single-needle package or other amounts of needles.

The face of the empty tray 420 illustrated in FIGS. 32(a) through 32(c)shows a plurality of grooves between raised tray portions formingclamping structures for accommodating the sequential placement of eightarmed surgical needles. In order to load the first armed needle into theempty tray 420, the tool nest 516 is indexed to workstation 600 as shownin FIG. 31. Simultaneous therewith, the rotary swage dial 150 asdescribed in detail below, indexes the multi-axis gripper 155 toworkstation 600. Then, the multi-axis gripper 155 is extended towardsthe empty tray 420 to deposit an armed needle 9 within a first pair 418of the eight paired sets of needle receiving notches 416 that are formedbetween protruding portions 419 in the bottom surface of the tray. Inthe preferred embodiment, each paired set of notches 418 isconsecutively numbered and spaced approximately 0.25 inches apart, asshown in FIG. 32(c). In the disclosed embodiment, the first needle 9loaded is in the eighth position as shown in FIG. 32(a). As illustratedin FIGS. 31 and 32(a) through 32(c), the tool nest 516 assembly and,consequently, the empty tray 420 is slightly tilted counter-clockwisefrom the vertical with respect to the orientation of the multi-axisgripper 155 so that the curved needle will be accurately depositedwithin the notches formed in the package. This tilt, which may be about10°-20°, and preferably 16° from the vertical, may be effected due tothe contact between the cams 530 and an angled or sloped camming surfaceon cam dial plate 533 at workstation 600. As a result of this tiltingoffset, the needles are slightly shifted relative to each other, and thesutures depending downwardly therefrom will not tend to tangle with eachother. Under control of the control system computer, a solenoid 455 thenactuates a push rod 460 to depress the plunger on the multi-axis gripper155 so that it may release its grip of the armed needle 9 in the mannerdescribed above.

As shown in FIGS. 31, 32(a) through 32(c), and 33(a) and 33(b), there islocated at the workstation 600 a package elevator assembly 430 thatregisters the empty tray 420 to receive eight individual armed needles,one at a time.

As illustrated in drawings, the tool nest 516 includes the mixed bodystructure 520 containing the rotatable shaft 528 at which there ismounted the package tray holding platform or support surface 542 and thepreviously-described structure. Most of the turret stations, which asshown in FIG. 25 of the drawings are in this case eight (8) in number,require that the tool nest 516 is precisely maintained in a non-rotatedvertical position, as illustrated specifically in FIGS. 26 and 28(a).This particular vertical orientation is maintained in that the circularstationary cam dial plate 533 extending between the collectiveworkstations is contacted by the two cam followers 530, which are in theform of cam rollers 530a and 530b mounted on shaft 528 so as to straddlethe longitudinal centerline of the latter, for each of the tool nestsmounted on dial 514.

Prior to needle insertion at the needle inserting workstation, the tray420 is adapted to be rotated into a tilted orientation throughpreferably an angle of 16° counter-clockwise so that needles are to bepositioned in a correct array and orientation in the needle parkstructure of the tray. This is attained by a tool nest rotatingstructure, as illustrated in drawing FIGS. 33(a) and 33(b), operating infunctional sequence essentially as follows:

FIG. 33(a) is an elevational view of the needle-suture load to packagestation 600 showing the indexing turret 514 upon which the tool nest 516has been mounted, consisting of the tray holding plate 540, includingthe tray supporting surface or platform 542. The shaft 528 is mounted insuitable bearings, (i.e. 529a and 529b) so as to be freely rotatablewithin the housing 520 of the tool nest 516, if required to do so.

As a specific tool nest 516 which has the tray mounted thereon at thefirst workstation, and which is adapted to be supplied with the needles,enters the needle and suture load to package workstation, in thedirection of arrow A, the tool nest 516 enters the tilt mechanism 535.The two cam followers 530, hereinafter designated as cam rollers 530aand 530b, roll along the upper surface of the stationary cam dial plate533, as illustrated by phantom lines at the left-hand side, and thenpass into the index mechanism 535 stopping in the position shown insolid lines in FIG. 33(b).

A track section 541 which consists of an insert having upper surface 543normally in coplanar relationship with the upper surface of the cam dialplate 533, and which extends through a cutout 545 formed in the cam dialplate 533, has its uppermost position determined by shoulders 543a and543b bearingly contacting against mating lower surfaces 545a and 545b onthe lower side of the stationary cam dial plate 533. Normally, the tracksection 541 is biased upwardly into the cutout 545 under the urging ofcompression springs 547 which are supported against a suitable springsupport member 549. At this position, the upper surface 543 of theinsert 541 is in the same plane as the upper surface of the cam dialplate 533.

A displacement cam element 551 is in a normally raised position abovethe cam rollers 530a, 530b to enable the latter to roll into the indexmechanism 535 workstation and enabling the tilting mechanism to operatewithout any interference of components in the rest or dwelling position,as illustrated.

In order to rotate or tilt the tool nest 516 for appropriate needleinsertion, an air cylinder 553 of the mechanism 551, which is attachedby means of suitable screws 555 to a plate structure 557 mounted abovethe camming dial plate 533; through a cylinder rod 559a of a pistondevice 559 causes the downward displacement of the cam element 551. Thisdownward motion is guided by a suitable sliding device (not shown). Thelower cam surface 551a of the displacement cam element 551 exerts adownward force against cam roller 530b which, in turn, forces the insert541 to move downwardly within the cutout 545 provided in the cam dialplate 533, compressing the springs 547, and thereby rotating the shaft528 in the housing 520 of the tool nest 516 counter-clockwise about axis528a. The downward movement continues until the upper surface portion551b of the displacement cam element 551 contacts the other cam roller530a which has been displaced upwardly an amount equal to the downwarddisplacement of cam roller 530b, and the system reaches the end oftravel, causing the air cylinder to maintain the position, as shown inFIG. 33(a). The foregoing results in a rotational movement of shaft 528to which the cam rollers 530a and 530b are fastened, and resultingly ofthe support surface 542 and tray mounted at the opposite other end ofthe shaft 528 in a counterclockwise direction, preferably to a tiltingangle of 16°.

After completion of the needle insertion operation, this sequence isreversed in that the air cylinder receives compressed air so as to raisethe displacement cam element 551. As a consequence, the springs 547cause the insert 541 to be biased upwardly, causing the upper surface543 thereof to press against the cam roller 530b and causing shaft 528to rotate clockwise. This continues until the shoulders 543a, 543bcontact the stationary surfaces 545a, 545b at the lower side of the camdial plate 533, thereby stopping this rotational motion. This clockwiserotation of the shaft 528 causes the cam roller 530a to move a lowerposition until it contacts the upper surface 543 of the insert 541 whichis now located in the same plane as the upper surface of the stationarycam dial plate 533. A suitable switch, for example, a proximity switch(not shown) now indicates that all of the mechanical components of thisarrangement have been returned to the original position of FIG. 33(a),and the dial 514 indexes the tool nest forward for the next operatingcycle. FIG. 33(b ) shows a dashed line representation of the cam rollers530a and 530b rolling on the surface of the tool cam dial plate 533towards the right, and the shaft 528 being displaced from thisworkstation.

This aspect provides a structure of providing a rotary tiltedpositioning of a product on an indexing turret, in this applicationrotation of the shaft 528 and tilting the package or tray mountedthereon by means of the support plate 536 and platform 542, such asthrough an angle within the range of 10° to 30°, and preferably about16°, due to the parallel offset distance between the camming surfaces551a, 551b on the displacement cam element 551 which contact the camrollers 530a and 530b.

In FIG. 33(c) there is disclosed schematically an alternative design,similar to the foregoing, however, in which the individual structuralcomponents of the tilting arrangement are combined into an integralmodular unit.

A shaft 446 of elevator assembly 430, as shown in FIG. 32(a), raises theplate 540 essentially vertically but slightly skewed (at about 11°) in0.25 inch increments to sequentially receive eight needles from themulti-axis gripper 155 as described above. In this embodiment, therotation of the swage dial 150 supplying armed needles from thepull-test station 300 at a rate of approximately 60/min. is synchronizedwith the vertical incrementing of the plate 540 mounting the tray 420 tomaximize production rates. For example, after inserting the first armedneedle 9 into the empty tray 420 into the paired notches numbered "8" asdescribed above, the elevator shaft 446 raises the plate 540 verticallyfor 0.25 inches so that the next armed needle 9 may be deposited in thepair of notches 418 numbered "7." Simultaneous with the registering ofthe tool nest plate 540, the rotary swage dial 150 indexes the nextmulti-axis gripper 155 carrying the second armed needle, so that it mayinsert the next needle in the second position (notch "7") of the tray420. This process takes place eight (8) times to fill a reduced sizeorganizer package containing eight (8) armed surgical needles. After theeighth needle has been inserted in the package, the elevator assembly430 retracts the elevator shaft 446 by conventional means such as apneumatic air cylinder (not shown). Thus, the tray 420 which is nowequipped with eight armed needles is in its initial position on the toolnest 516 and the tray is ready for further treatment at successiveworkstations.

Upon the requisite number of needles having been parked in the tray; forexample, eight needles, the grippers 155 for transporting needles to thetray cease operation, and the rotary dial 514 indexes to the nextworkstation, while a subsequent tray may be positioned indexed in frontof the needle dispensing unit so as to, in turn, be capable of beingequipped with needles and attached sutures, as was the preceding tray420.

Needle detecting station

(4) The optional fourth of the successive workstations located about therotary suture wind and package dial is the needle detector workstation475 which may be provided for verification of the presence and properpositioning of the needles and sutures having been introduced into thetray 420 by the multi-axis gripper 155, as described above. As shown inFIG. 34, needle detector unit 560 consisting of a stationary bracketunit 561 is adapted to be positioned opposite the platform 542 indexedin front thereof and mounting the needle-filled tray 420, and thenadvanced axially towards the latter to enable a plurality of sensors 562mounted on a housing 564 movable thereon and interfaced with controlsystem 99 to ascertain that the appropriate number of surgical needleshave been properly introduced into and parked in proper array in thetray 420 by the multi-axis gripper 155 at the preceding workstation 600.Upon the needle sensors 562 verifying to the control system 99 thepresence of the required quantity and parking of the surgical needles inthe tray 420, the sensors 562 and housing 564 are retracted away fromthe tray 420 on platform 542 to enable the suture wind and packagingturret 500 to index the tool nest 516 forwardly to a furtherworkstation.

Suture Winding Station

(5) A suture winding workstation 550, to which the tray 420 is adaptedbe indexed, comprises a suture winding apparatus 570, by means of whichsutures depending from the needles outwardly of and hanging downwardlyfrom the tray 420 are wound into the confines of the tray 420, andparticularly the peripheral channel as illustrated in FIG. 46, and asshown in FIGS. 35(a), 35(b), 35(c) and 36 of the drawings. Thedownwardly loosely hanging sutures extending from each of the needles,as described hereinbelow, are positionable so as to be tensioned in astationary vacuum device or unit 572 located below the tool nest 516supporting the suture tray 420 at this workstation, and to thereby causethe sutures to be tensioned and bundled into a compact strand, theoperational sequence of which is illustrated in and described in moreextensive detail hereinbelow with regard to FIGS. 35(a) through 35(c) ofthe drawings directed to the operational aspects of winding apparatus570.

The cam plate member 536 of the tool nest mounting the needle andsuture-filled tray 420 on platform 542 at this workstation is adapted tobe contacted along the cam surface 538 thereof by cam followercomponents 574 located on a stylus arrangement 576 of apparatus 570,which is employed for guiding and winding the sutures into theperipheral channel of the tray 420. The stylus arrangement 576 includesa stationary cylinder 578 having a pneumatically-actuatable centralpiston 580 longitudinally reciprocable therein for movement towards andaway from the tray 420. The cam follower components 574 comprisearticulatingly connected rollers 574a and 574b contacting the peripheralcam surface 538 of the cam plate member 536, the latter of which, inconjunction with the support plate 540 mounting the tray 420, is rotatedby the computer-controlled rotation of shaft 528 about a horizontalcentral axis 528a extending normal to the plane of the plates 536, 540and the tray 420 so as to facilitate winding of the sutures into theperipheral channel of the tray 420, as shown and elucidated with regardto the description of operation of FIGS. 35(a) through 35(c) and 36.

Referring more specifically to the construction of the tray 420 shown inFIG. 46 of the drawings, which as indicated hereinabove is essentiallythe needle and suture-containing tray 420 constituting, in combinationwith an attached cover, the components of the multi-strand suturepackage of the above-mentioned U.S. Pat. No. 5,230,424. Referring to thebasic constructional features thereof, the tray 420 has a planar base580 of generally rectangular configuration extending into roundedcorners 582. Extending about the periphery of the base 580 is anupstanding wall 584, and spaced inwardly thereof in parallelrelationship is a further upstanding wall 586 so as to form a peripheralchannel structure 588 therebetween. Extending over the channel 588outwardly from the inner wall 586 are a plurality of contiguouslyarranged essentially resilient retaining fingers 590, which arecantilevered so as to extend most of the way over the channel 588 fromthe upper edge of the inner wall thereof for preventing sutures fromlifting up out of the channel. A gap 592 formed in the array of theretaining fingers 590 along the length of the channel, preferablyproximate the juncture or corner between two of the rectangular sides ofthe tray 420 permits the end of each of the sutures to emerge from thechannel 588, as shown in FIG. 46 of the drawings.

The central region of the base 580 of the tray 420 within the inner wall586 includes integral structure which provides a plurality ofspaced-apart gaps enabling the clamping therein of the suture needles soas to "park" the latter in the tray 420, as is clearly shown in thedrawing and described in detail above, and with each of the needleshaving one end of a respectively associated suture attached or swagedthereto.

The functioning of the components of the stylus arrangement 576 forwinding the suture into the tray 420 is described in more extensivedetail in connection with FIGS. 35(a) through 35(c) of the drawings,illustrating more specifically the vacuum unit 572, a pivotable leverwhich is operable in conjunction therewith for tightening and tensioningthe suture bundle, and the stylus arrangement 576 cooperating with theresilient fingers 590 of the tray 420 in order to feed the sutures intothe channel in a winding motion as the tray 420 is being rotated by itssupporting platform 542 due to rotation of shaft 528 about axis 528a.

Adjacent the winding station and extending over the stylus arrangement576 as shown in FIGS. 37 and 38 of the drawings, there is arranged atray restraint device 601 which comprises L-shaped brackets 602 havingupright legs 604 thereof fastened to a stationary surface, and topportions 606 extending horizontally over the rotary dial 514 and thedial cam plate 533 thereon, and being operatively connected through asuitable drive arrangement 608 with an inner end of the shaft 528extending through the housing 520 and which is connected with the camplate 536 and plate 540 mounting the suture tray. A shaft 610 extendsthrough legs 604 of the stationary bracket 602 and upon initiation ofthe suture winding operation, is displaced axially towards the tray 420,either pneumatically or electrically by control means 99 such that arestraint plate 612 contacting the outwardly facing tray 420 surfacecomes into operative engagement with at least a center portion thereofso as to inhibit the tray 420 from being expelled outwardly from itsmounted position on the platform 542 during the suture winding sequence,and, to prevent the sutures from being pulled out from their associatedneedles by the tension imparted to the bundled suture strands. Theinterengagement of the restraint plate 612 and the tray 420, and therotation imparted to the shaft 528, will cause the shaft 610 in the legmember 604 of the bracket 602 of the restraint arrangement to rotate inconjunction with the rotation of shaft 528. Upon completion of thewinding procedures, the control system 99 will cause the restraint plate612 to be shifted away from the tray 420 into an inoperative position,so as to enable the tray 420 on its tool nest 516 to be indexed to afurther workstation by the advance of the rotary dial 514 in thedirection of arrow A of FIG. 38.

As shown in FIG. 35(a), the rotary dial 514 has just indexed to thesuture winding workstation with a tray 420 attached to its platform 542.In this position, the bundle of sutures, in this instance, eight sutureseach respectively attached to one of the surgical needles parked in thetray, hang downwardly from the tray and enter the vacuum gatheringdevice 572 which has an internal V-section 573 wherein a generatedvacuum applies tension to the sutures and collects and stretches theminto a bundled strand. The vacuum is created by a vacuum being pulledfrom an exhaust port 573a which creates an airflow into the "V" shapethrough suitable vent holes 573b. The gathering of the suture bundle isindicated as step 61 in FIG. 3(d). Concurrently, as shown in FIGS. 35(a)through 35(c), the entire tray supporting platform 542 and cam platemember 536 are subjected to rotation about axis 528a in the direction ofarrow B responsive to the operation of shaft 528 by means of aprogrammable servomotor 613, as illustrated schematically in FIGS. 37and 38.

As shown in FIG. 35(a), the turret index which has moved the tray to thesuture winding station is complete, and this motion has dwelled inpreparation for the winding function for the sutures.

The suture winding workstation as illustrated in FIG. 25 of the turret500 includes structure for rotating the package and to accomplish thesuture winding operation. This is accomplished by a motorized drivingmechanism as shown in FIGS. 39(a) through 39(c) and 37. The primaryrotary dial 514 as shown in FIG. 37 which has the tool nest 516 thereoncontaining shaft 528 mounted in suitable bearings 529a, 529b in housing520.

As the winding machine is indexed for a next suture winding cycle, thetool nest 516 is moved into the rotational station 680 as shown in FIG.39(a), indicated by arrow C. The cam rollers 530a and 530b cross a gap682 provided in the stationary cam dial plate 533 and enter a slot 684formed by opposite parallel surfaces 686, 688 formed in a driven roller690, the latter of which extends partly into the gap 682 produced by acutout provided in the cam dial plate 533. The lower surface 688 of slot684 is normally substantially in coplanar and axial alignment with theupper surface of the cam dial plate 533 enabling the rollers 530a and530b to be centered therein. This centering action takes place in adwell position of the dial 514 in the suture winding workstation,whereby the longitudinal centerline 528a of shaft 528 is coincident withthe centerline of the driven roller 690. The drive roller 690 is mountedin suitable bearings such as to be able to be rotated by the servomotor613 driving a timing belt 692 extending from a driving roller 694 to thedriven roller 690 so as to operatively interconnect the rollers 690,694.

When the winding cycle is started at the suture winding station, asshown in FIG. 35(a), the servomotor 613 drives the driving roller 694which, in turn, drives the driven roller 690 through the timing belt692. At the end of the winding operation, the driven roller 690 isstopped to cause a horizontal orientation to be assumed by the slot 684and the opposite surfaces of the slot are coplanar or coextensive withthe upper surface of the cam dial plate 533. The dial 514 then indexesin the direction of arrow D, advancing the cam rollers 530a and 530b outof the slot 684 of the driven roller 690 and onto the upper surface ofthe tool camming plate 533, thereby locking the support plate and trayinto a vertical tray orientation which is secured against rotation. Asuitable switch, such as a proximity switch (not shown) assures that thedriven roller 690 is in the horizontal slot orientation before indexingthe dial 514 forwardly, thereby preventing any mechanical interferencebetween components which could damage the latter. The rollers 690 and694 may be suitable sprocket wheels, and the timing belt 692 a sprocketbelt or chain.

The programmable servomotor 613 which rotates shaft 528 having the toolnest 516 fastened thereto and, effectively, the support platform 542 andcam plate 536 for the tray 420 about its center rotational axis 528a hascompleted an initial counter-clockwise rotation in the direction ofarrow B, causing the suture bundle to wrap around a pin 575 whichprotrudes from the suture tray towards the viewer, when looking into theplane of the drawing. This rotation pulls the suture bundle partiallyout of the vacuum gathering device 572, which imparts a predeterminedtension to the suture bundle causing it to become straight and theindividual strands or sutures to be collected into a parallel andtightly confined group. The winding stylus assembly 576 which is mountedon a stationary plate is shown in its retracted position in cylinder578, as it is during turret index.

In FIG. 35(b), the subsequent phase of the winding operation isillustrated wherein a suture positioning arm 577 has been actuated torotate clockwise, bringing a roller 577a to bear against the suturebundle, thereby implementing two functions:

(a) The suture bundle length is increased between the pin 575 and thevacuum device 572 causing additional suture length to be drawn out ofthe vacuum device and resulting in a tighter more confined suturebundle.

(b) Moreover, the foregoing displaces the suture bundle towards theright, so that a winding stylus 579 having fingers or legs 579a and 579bcan straddle the bundle in the now extended position of the stylusarrangement, and be dropped on the floor of the tray channel 588 (in amotion perpendicular to the plane of view into the drawing) with areasonable assurance that the bundle strands will not become pinched orfall outside of the stylus legs 579a, 579b.

FIG. 35(b) also illustrates the winding stylus assembly 576 extendedtowards the tray 420 by the extension of the air cylinder 581 until thestylus guide rollers 574a, 574b contact the peripheral cam surface 538of the tool nest. This step is indicated as step 67 in FIG. 3(d). Theair cylinder 581 maintains a force against the rollers 574a, 574b duringrotation of the tray 420 for winding, acting in a manner of a spring asthe rollers force the stylus head 579 and the slide 583 to oscillate.The slide oscillates within the stationary slide holder 585.

FIG. 35(c) illustrates the commencement of the tray rotation on thesupport surface 542 for effectuating winding of the sutures. The aircylinder exerts a constant force on the slide 583, and through a pivotpin 587 to the roller assembly 574a, 574b. The stylus 579, which ismounted in the roller assembly is maintained at 90° relative to thesuture track by this action. The enlarged encircled detail view of FIG.36 discloses the suture bundle after it is positioned below theresilient suture-retaining tray fingers 590. This also illustrates themanner in which the stylus 579 plows under the tray fingers, raising andlowering them progressively as it leads the suture bundle therebeneathand guides the bundle into the peripheral channel 588 of the tray 420.As this winding takes place, as indicated at step 70 in FIG. 3(d), thevacuum device 572 maintains a constant essentially gentle tension on thesuture bundle as it is withdrawn therefrom, and this action continuesuntil the suture bundle ends withdrawn from the vacuum device are fullyinserted by the stylus 579 under the resilient tray fingers 590 into theperipheral suture tray channel 588. At this final point of the windingcycle, the tool nest 516 mounting the tray is rotated to position thestylus in the suture channel window or gap 592, as shown in FIG. 46,whereupon the stylus 579 is raised upwardly out of the tray and the aircylinder retracts the stylus assembly, i.e. the piston rod mounting thelatter, to the position shown in FIG. 35(a). Rotation of the tool nestmounting the tray with the needles parked therein and the sutures woundinto the channel 588 continues in a counter-clockwise direction untilthe needle park is vertical with the needle points extending downwardly.The rotary disc 514 is then indexed for the next cycle, in effect, forreceiving and winding a subsequent tray.

During the foregoing suture winding sequence of operation, as previouslymentioned, the restraint device 601 continually maintains its contactwith the tray so as to prevent the tray and the contents therein frombeing expelled from the support platform 542 on which the tray 420 ismounted, and also to prevent the sutures from being pulled out from theneedles. The restraint device 601 is withdrawn from the tray 420 uponcompletion of the suture-winding procedure to enable the continuedforward indexing rotation of rotary turret 510. Additionally, drivemember 530a and cam followers 530 located therein are returned to ahorizontal position so the cam followers can leave the slot 684 andre-enter on top of cam plate 533 without mechanical interference as dial510 indexes for the next cycle.

(6) At the above-mentioned optional workstation 625 of FIG. 1, thepackage tray 420 and its contents are exposed to external visualinspection to facilitate a viewer or video camera to ascertain whetherany of the sutures extend outwardly of the channel or tray, and whetherthe needles are properly parked in the tray and attached to theirassociated sutures. This optional step is indicated as step 73 in FIG.3(d).

(7) At a cover-applying and attaching workstation 650, as shown in FIG.1, to which the tray 420 is to be indexed from the preceding optionalinspection workstation, there is located a cover-applying apparatus 620incorporating a pressing die structure 622 for attaching a cover to thetray 420, as illustrated in FIGS. 40 through 42 of the drawings, and forproducing the suture package as shown in FIG. 47.

The process of attaching a cover to the package tray is indicated atsteps 77 and 80 in FIG. 3(d).

The apparatus 620 which is essentially mounted on a suitable fixedsupport proximate to the perimeter of the rotary turret, includes anupstanding framework 624 which includes a pivot arm structure 626pivotally mounted therein and being articulatable about a horizontalpivot axis 628 for movement between a vertical position facing thebottom end 630 of a cover supply hopper or chute 632 and a horizontalposition facing a tray mounted on platform 542 which has been indexed tothis workstation. For purposes of illustration only, in FIG. 40 both thehorizontal and vertical positions of the pivot arm 622 are illustrated,as pivotable along the direction of double-headed arrow C. A coverpressing die 623 is mounted at the outer or free end of the pivot arm626, with a plurality of resistant vacuum cups for engaging and holdingthe cover as it is withdrawn from hopper 632.

The pivot arm structure 626 with the pressing die 623 therein, whenupright, is adapted to engage and withdraw a tray cover which isdimensioned in conformance with the configuration of the tray, and inthe presence of a tray having the needles and wound sutures containedtherein at the workstation, the pivot arm 622 with the pressing die 623at its outer free end and the cover positioned thereon is swung intohorizontal axial alignment with the tray on the support platform 542, asshown in FIG. 40, and through suitable actuating means, such as by meansof a pneumatic device 628, the arm 622 with pressing die 623 thereon isextended towards and into contact with the tray on platform 542 so as toposition the cover on the tray. The pressing die 623 contains suitablesurface structure, as shown in FIG. 42, for fastening the cover to thetray, as explained hereinbelow.

The tray cover 651 is basically a flat cover which may be of a suitablyimprinted paperboard or the like material, and is applied to be fastenedto the tray 420 by means of pressing die 623, as shown in FIG. 47, withthe outer dimensions of the cover as previously mentioned beingsubstantially coextensive with the peripheral dimensions of the tray,and with the cover also having apertures 652 in registration with theupstanding guide pins 544 on the platform 542.

Hereby, the surface of the pressure die 623 facing the cover includes afirst surface portion 638 substantially in conformance with the flatsurface of the cover 651 which has been superimposed on the tray 420,and includes three projecting posts 634, preferably at three sides aboutthe surface 638, and as shown in enlarged scale in FIG. 48 of thedrawings, which will engage tabs 653 which overlie recessed portions 654of the tray, and cause the pre-cut tabs 653 to be displaced along threeedges thereof, and thereby forming latching tabs 656 which are pressedin V-shapes downwardly into the respective recesses 654 so as to havethe separated edge of the folded tab 656 at that particular locationengage beneath a horizontal wall structure 658 of the tray 420 extendingpartially over the recess 654, thereby latching the cover 651 intocooperative engagement with the upper surface of the tray at threelocations.

Concurrently, a second raised die surface portion 660 on the surface 638of the pressing die 623 engages into a surface region 662 defined bysuitable raised wall structure 664 on the tray 420 shown in FIG. 46. Dieportion 660 and wall 664 form therealong a peripheral mutuallycooperating shear edge to separate a portion 668 from the cover 651 inconformance with the area 662. Second die portion 660 pushes theseparated cover portion 668 downwardly into that area 662 of the tray soas to be secured therein separate from the remaining structure of cover651. The separated portion 668 is permanently retained recessed withintray 420 by one or more ribs 671, as illustrated in FIGS. 46 and 48which are formed in wall 664, so as to form a product-identifying labelremaining in the tray upon subsequent detachment of the cover 651 fromthe tray 420.

(8) Responsive to indexed forward rotation of the rotary dial 514 ofsuture wind and package machine 500 to a successive workstation, thesuture package consisting of the needle and suture-containing tray 420and attached cover 651, as shown in FIG. 47, is positioned in alignmenton the platform 542 with a package removal unit 670, as illustrated inFIGS. 43 to 45 and indicated at step 83 in FIG. 3(e). In FIG. 43 of thedrawings, a pivoting arm structure 673 is illustrated in both itshorizontal and vertical operative positions, being pivotable along thedirection of double-headed arrow D. Suitable grippers 926 are mounted onthe pivoting arm structure 673 which is journaled on a stationary frame674 the latter of which is somewhat similar in structure to theframework 624 of the cover-applying apparatus 620. These grippers 926are pivotable into a horizontal orientation and extend outward from arm673 as a result of pneumatically operated ram 682, as shown in FIG. 43,for gripping engagement with the suture package. The ram 682 and gripper926 is then operated to retract and withdraw the suture package from itssupport surface or platform 542 and the pins mounted thereon.

Prior to unloading the completed package, a check is made as to thestatus of an error bit flag that may have been set during thenon-destructive suture pull-test depending upon if the suture pull-testhas failed. Similarly, at the needle detect station 475, a reject bitmay or may not have been set indicating that the package does notcontain the proper amount of needle-suture assemblies. Therefore, if itis determined that the reject bit had been set indicating a rejectedpackage, the control system 99 will command the unload package gripperfingers 926 to release its grip on the package, and, essentially, dropthe package into a reject bin as indicated at step 89 in FIG. 3(e).

The gripper 926 with the therewith clamped suture package is thenadapted to be pivoted upward into a vertical orientation in alignmentwith the opening 676 in the bottom 678 of a hopper or chute 680 forreceiving a stack of completed suture packages through the upwardpushing action of a pneumatic cylinder 682 biasing the suture packagesinto the chute 680, as shown in FIGS. 43 and 45 and indicated as step 87in FIG. 3(e). The bottom 678 of the chute includes a retaining lip 684to prevent the suture packages from falling downwardly out of the chute.Subsequently, the biasing ram 682 and gripper 926 is pneumaticallyretracted within the arm structure 673 which is pivoted to itshorizontal position to receive the next completed suture package.Alternatively, this particular, basically optional structure forremoving the completed suture package from the support surface may beeliminated, if desired, and replaced by a manual suture package-removingoperation.

From the chute 680, the suture packages may then be removed eitherthrough the intermediary of a further mechanism (not shown) or manuallytransported for additional processing; for example, such as sterilizing,and/or additional overwrapping, or the like.

While the invention has been particularly shown and described withrespect to the preferred embodiments thereof, it will be understood bythose skilled in the art that the foregoing and other changes in formand details may be made therein without departing from the spirit andscope of the invention, which should be limited only by the scope of theappended claims.

What is claimed:
 1. An automated process for attaching a suture strandto a surgical needle having a suture receiving opening formed therein,and for packaging a needle-suture assembly in a package tray, saidprocess comprising the steps of:(a) sorting a plurality of needles andorienting each needle for automatic sequential feeding thereof to afirst indexing means for transfer to a subsequent swaging workstation;(b) sequentially swaging each of said fed needles to close said suturereceiving opening of each respective needle about a free end of acorresponding suture strand to secure said suture strand thereto andform a needle-suture assembly at said swaging workstation for automaticsequential feeding thereof to a needle packaging station by said firstindexing means; and, (c) sequentially depositing each formedneedle-suture assembly in a package tray at said needle packagingstation, one needle-suture assembly being deposited in said package trayat the same time said swaging of a subsequent needle about a subsequentcorresponding suture strand occurs at said swaging workstation, and, atthe same time said sorting of said plurality of needles takes place. 2.An automated process for attaching a suture strand to a surgical needlehaving a suture receiving opening formed therein, and for packaging aneedle-suture assembly in a package tray, said automated processperformed by an automated machine performing multiple simultaneousoperations during each machine cycle, said process comprising the stepsof:(a) sorting a plurality of needles and orienting each needle forautomatic sequential feeding thereof to a first indexing means fortransfer to a subsequent swaging workstation during said each machinecycle; (b) sequentially swaging each of said fed needles to close saidsuture receiving opening of each respective needle about a free end of acorresponding suture strand to secure said suture strand thereto andform a needle-suture assembly at said swaging workstation during eachmachine cycle, said first indexing means sequentially feeding one saidformed needle-suture assembly from said swaging workstation to a needlepackaging station during said each machine cycle; and, (c) sequentiallydepositing each formed needle-suture assembly in a package tray at saidneedle packaging station, one needle-suture assembly being deposited insaid package tray during said each machine cycle.
 3. The automatedprocess for attaching a suture to a surgical needle and for packaging aneedle suture assembly in a package tray as claimed in claim 1 or 2wherein said sorting step (a) further includes the steps of:(a)depositing a predetermined amount of needles upon a first conveyormeans; (b) obtaining an image of said needles deposited upon said firstconveyor means and converting said image into digital signals; (c)processing said digital signals to obtain positional and orientationdata for a selected randomly positioned needle upon said first conveyormeans; and (d) removing said randomly positioned needle from said firstconveyor means based upon its respective positional and orientationdata, and positioning it upon a second conveyor means for conveyance tosaid first indexing means.
 4. The automated process for attaching asuture to a surgical needle and for packaging a needle-suture assemblyin a package tray as claimed in claim 1 or 2 wherein said swaging step(b) further includes the steps of:(a) sequentially feeding a pluralityof needles and a plurality of associated sutures to a pair of swagingdies, with a first of said pair being adjustably fixed; (b) sequentiallyinserting a free end of each of said sutures into an associated suturereceiving opening formed in each of said plurality of needles prior toswaging thereof; and (c) driving a second of said pair of swaging diestowards the adjustably fixed swaging die to swage each of said needlesto an associated suture.
 5. The automated process for attaching a sutureto a surgical needle and for packaging a needle-suture assembly in apackage tray as claimed in claim 4 wherein the step (a) of sequentiallyfeeding a plurality of needles and a plurality of associated sutures toa pair of swaging dies further includes the steps of:(a) moving a secondswaging die having an end thereof defining a portion of a swage dieopening away from a first fixed swaging die having an end thereofdefining another portion of said swage die opening; (b) positioning saidsuture receiving opening of each respective needle in said swage dieopening; (c) moving said second swaging die toward said first swagingdie with a force sufficient to grip said needle placed in said swage dieopening without deforming said suture receiving opening of said needle.6. The automated process for attaching a suture to a surgical needle andfor packaging a needle-suture assembly in a package tray as claimed inclaim 5 further including the step of adjusting the position of saidfirst swaging die to change the amount of swage deformation imparted tosaid suture receiving opening during swaging thereof.
 7. The automatedprocess for attaching a suture to a surgical needle and for packaging aneedle-suture assembly as claimed in claim 4 further including the stepsof:(a) sequentially indexing each formed needle-suture assembly to apull-test workstation located between said second workstation and saidneedle packaging station; (b) pull-testing each nth needle-sutureassembly to obtain an nth sample failure value.
 8. The automated processfor attaching a suture to a surgical needle and for packaging aneedle-suture assembly as claimed in claim 7 further including the stepsof:(a) comparing said nth sample failure value with a low failurethreshold value to generate a first signal if said nth sample failurevalue is below said low failure threshold value; and (b) incrementallyadjusting the position of said adjustable first swaging die in responseto said first signal to move said first swaging die an incrementaldistance towards the second swaging die.
 9. The automated process forattaching a suture to a surgical needle and for packaging aneedle-suture assembly as claimed in claim 7 further including the stepsof:(a) comparing said nth sample failure value with a high failurethreshold value to generate a second signal if said nth sample failurevalue is above said high threshold value; (b) incrementally adjustingthe position of said adjustable first swaging die in response to saidsecond signal to move said adjustable first swaging die an incrementaldistance away from the second die.
 10. The automated process forattaching a suture to a surgical needle and for packaging aneedle-suture as claimed in claim 8 or 9 wherein said first of said pairof swaging dies includes a wedge follower located at one end thereof andincluding a wedge assembly positioned to move transverse to said wedgefollower, wherein the step of incrementally adjusting the position ofsaid adjustable first swaging die further includes the steps of:(a)inputting either of said first and second signals to a servomotor meansfor precisely rotating a swage adjust screw of a predetermined pitch inaccordance with either of said first and second signals; (b) translatingsaid rotation of said swage adjust screw into linear motion of saidwedge assembly, said wedge assembly moving transverse to said wedgefollower of said first swaging die; and (c) moving said wedge followerof said first swaging die in incremental units correlating with saidtransverse linear motion of said wedge assembly.
 11. The automatedprocess for attaching a suture to a surgical needle and for packaging aneedle-suture assembly as claimed in claim 7 wherein step (b) of pulltesting each nth needle-suture assembly further includes the stepsof:(a) supporting the needle of said nth needle-suture assembly; (b)gripping the associated suture of said nth needle with a gripping means,said gripping means including a means for applying a predeterminedamount of force to said suture; (c) applying said force to said suturewhile said suture is gripped by said gripping means; and, (d) measuringsaid force applied to obtain said nth sample failure value.
 12. Theautomated process for attaching a suture to a surgical needle and forpackaging a needle-suture assembly in a package tray as claimed in claim1 or 2 wherein said depositing step (c) further includes the step ofincrementally moving a package tray support means having said packagetray supported thereon in correlation with said sequential feeding ofneedle-suture assemblies to said package tray by said first indexingmeans to register each needle-suture assembly with a correspondingposition in said package tray, said first indexing means successivelydepositing each needle-suture assembly to said package tray with asingle needle-suture assembly deposited at each registered position. 13.The automated process for attaching a suture to a surgical needle andfor packaging a needle-suture assembly as claimed in claim 12 furtherincluding the step of mounting an empty package tray on said packagetray support means at a package tray loading workstation, said secondindexing means indexing said empty package tray to said needle packagingstation.
 14. The automated process for attaching a suture to a surgicalneedle and for packaging a needle-suture assembly as claimed in claim 12further including the step of applying a cover to said package tray toform a completed suture package containing said needles and attachedsutures, said cover being applied by a cover applying means at a coverloading workstation.
 15. The automated process for attaching a suture toa surgical needle and for packaging a needle-suture assembly as claimedin claim 14 further including the step of disengaging said completedsuture package from said package tray support means at a package removalworkstation.
 16. The automated process for attaching a suture to asurgical needle and for packaging a needle-suture assembly as claimed inclaim 14 wherein said cover applying means includes a pivotable armhaving grippers for gripping said covers, said process further includingthe steps of:(a) successively obtaining individual covers from a supplyof covers; (b) pivoting said grippers into alignment with said tray onsaid package tray support means; (c) extending said grippers to positiona cover gripped thereby on said tray, (d) releasing said cover; and, (e)withdrawing said grippers.
 17. The automated process for attaching asuture to a surgical needle and for packaging a needle suture assemblyin a package tray as claimed in claim 1 or 2 further including the stepsof:(a) indexing said package tray having one or more of said formedneedle-suture assemblies deposited therein from said needle packagingstation to a suture winding station, said indexing performed by a secondindexing means; and, (b) automatically winding said sutures of said oneor more needle-suture assemblies into said package tray at said suturewinding station.
 18. The automated process for attaching a suture to asurgical needle and for packaging a needle suture assembly in a packagetray as claimed in claim 17 wherein said winding step (b) furtherincludes the steps of:(a) gathering depending suture portions of saidneedle-suture assemblies into a bundle of strands and imparting axialtension thereto; (b) contacting said bundle of strands with a stylusmeans, said stylus means for guiding said bundle of strands into aperipheral channel of said package tray; and, (c) simultaneouslyimparting rotational movement to said package tray with a drive means towind said depending sutures of said needle-suture assemblies into saidperipheral channel of said package tray.
 19. The automated process forattaching a suture to a surgical needle and for packaging aneedle-suture assembly as claimed in claim 18 wherein the step ofgathering said depending suture portions includes the step of impartinga subatmospheric pressure to cause said depending suture portions to betensioned into said bundle of strands.
 20. The automated process forattaching a suture to a surgical needle and for packaging aneedle-suture assembly as claimed in claim 19 wherein the step ofwinding said bundle of strands further includes the steps of:(a)contacting said tensioned suture portions with an arm structure means;and (b) pivoting said arm structure means to bias said-tensioned sutureportions into an orientation facilitating winding of said sutureportions into said peripheral tray channel.
 21. The automated processfor attaching a suture to a surgical needle and for packaging aneedle-suture assembly as claimed in claim 18 wherein said stylus meansincludes stylus legs for contacting said bundle of strands, a piston rodfor mounting said stylus legs at one end thereof for axial movement,and, a stationary piston cylinder within which said piston rod ismounted, said process further including the step of exerting pressurizedair against said piston rod within said stationary piston cylinder toprovide reciprocatory motion thereof to enable said stylus legs toengage into and follow said peripheral tray channel during rotation ofsaid tray.
 22. The automated process for attaching a suture to asurgical needle and for packaging a needle-suture assembly as claimed inclaim 21 wherein said package tray is supported on a package traysupport means including a cam plate, and said stylus means furtherincludes cam follower means mounted on said piston rod proximate saidstylus legs, said process further comprising contacting a peripheralcamming surface on said cam plate by said cam follower means in responseto said pressure being exerted against said piston rod by pressurizedair in said piston cylinder.
 23. The automated process for attaching asuture to a surgical needle and for packaging a needle-suture assemblyas claimed in claim 22 wherein said tray includes a plurality ofresilient cantilevered fingers extending over said peripheral channelfor protectively maintaining the sutures in said channel, said styluslegs engaging beneath successive of said fingers for raising saidfingers during rotation of said tray to guide said bundle of strandstherebeneath and bias said bundle of strands into and towards the bottomof said tray channel.
 24. The automated process for attaching a sutureto a surgical needle and for packaging a needle-suture assembly asclaimed in claim 18 wherein said package tray is supported on a packagetray support means and rotated thereby during winding of said bundle ofstrands, said process further including the step of inhibitingdisplacement of said package tray on said package tray support means bycontacting said tray with a restraint means during rotation of saidtray, wherein said restraint means is operatively connected to saiddrive means.